Data / Medical devices / South Korea / SCL Science Inc.
SCL Science Inc.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
SCL Science Inc. is registered with the FDA (registration 3014136088) in Seoul, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 29, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014136088
- Address
- #1206-1210, ACE hightechcity 2 25, Seonyu-ro 13-gil, Yeongdeungpo-gu, Seoul, South Korea, 07282
- Owner or operator
- InnoTherapy Inc. (10053735)
- Roles
- Manufacturer
- First device listed
- January 5, 2017
- Registered through
- 2026
- Brand names listed
- InnoSEAL Hemostatic Pad
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 29, 2016 | K161013 | InnoSEAL Hemostatic Pad | QSY | Substantially Equivalent | Innotherapy, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 29, 2016. 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.