Data / Medical devices / United States / Apex Aseptic Products
Apex Aseptic Products: FDA-registered device maker in Voorhees, NJ, United States, 1 510(k) clearance
Apex Aseptic Products is registered with the FDA (registration 3019458442) in Voorhees, NJ, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019458442
- Address
- 2 Executive Drive, Voorhees, NJ, United States, 08043
- Owner or operator
- MaxCare Products, LLC (10075148)
- Roles
- Specification developer
- First device listed
- August 4, 2020
- Registered through
- 2026
- Brand names listed
- Apex Aseptic / AseptiCor / AsViro / MaxCare / Denline
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Specification developer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Specification developer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Specification developer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 7, 2004 | K040333 | VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS | FXX | Substantially Equivalent | Valumax Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Suit, Surgical
- All makers of Non-Surgical Gown
- All makers of Accessory, Surgical Apparel
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Cap, Surgical
- All makers of Mask, Surgical
Updated June 7, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.