The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Gel-sponge Ent, Absorbable Gelatin Sponge, Usp.
| Device ID | K080022 |
| 510k Number | K080022 |
| Device Name: | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Deborah Neymark |
| Correspondent | Deborah Neymark VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-03 |
| Decision Date | 2008-12-09 |
| Summary: | summary |