Data / Medical devices / United States / Peter Lazic Us Inc
Peter Lazic Us Inc: FDA-registered device maker in Topsham, ME, United States, 1 510(k) clearance
Peter Lazic Us Inc is registered with the FDA (registration 3010739934) in Topsham, ME, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 5, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010739934
- Address
- 22 Clipper Way, Topsham, ME, United States, 04086
- Owner or operator
- peter lazic us inc (10046256)
- Roles
- Complaint file establishment
- First device listed
- April 30, 2024
- Registered through
- 2026
- Brand names listed
- Hoboat
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| December 5, 2023 | K231615 | Disposable Endoscopic Bipolar | GEI | Substantially Equivalent | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 5, 2023. 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.