The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Geliperm Absorbind Granulated Gel.
| Device ID | K850819 |
| 510k Number | K850819 |
| Device Name: | GELIPERM ABSORBIND GRANULATED GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | GEISTLICH-PHARMA ARENT, FOX, KINTNER, PLOTKIN & 1050 CONNECTICUT AVENUE Washington, DC 20003 -6 |
| Contact | Peter S Reicherta |
| Correspondent | Peter S Reicherta GEISTLICH-PHARMA ARENT, FOX, KINTNER, PLOTKIN & 1050 CONNECTICUT AVENUE Washington, DC 20003 -6 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-28 |
| Decision Date | 1985-05-07 |