Data / Medical devices / United States / Integrated Commercialization Solutions, LLC
Integrated Commercialization Solutions, LLC: FDA-registered device maker in Brooks, KY, United States, 1 510(k) clearance
Integrated Commercialization Solutions, LLC is registered with the FDA (registration 3002478693) in Brooks, KY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002478693
- Address
- 420 International Blvd, Ste 500, Brooks, KY, United States, 40109
- Owner or operator
- AmerisourceBergen Corporation (10046538)
- Roles
- Repackager or relabeler
- First device listed
- April 11, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hydrogel Spacer | OVB | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 26, 2022 | K220641 | Barrigel Injectable Gel | OVB | Substantially Equivalent | Palette Life Sciences | accessdata.fda.gov |
Compare with other makers
Updated May 26, 2022. 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.