The following data is part of a premarket notification filed by Satelec with the FDA for Hemostasyl Paste.
| Device ID | K082116 |
| 510k Number | K082116 |
| Device Name: | HEMOSTASYL PASTE |
| Classification | Cord, Retraction |
| Applicant | SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-07-28 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760243000959 | K082116 | 000 |
| 03760243000942 | K082116 | 000 |
| 03760243000935 | K082116 | 000 |