Geistlich Derma-Gide
Dressing, Wound, Collagen
Geistlich Pharma AG
The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Derma-gide.
Pre-market Notification Details
| Device ID | K182838 |
| 510k Number | K182838 |
| Device Name: | Geistlich Derma-Gide |
| Classification | Dressing, Wound, Collagen |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH Ch-6110 |
| Contact | Marco Steiner |
| Correspondent | Samie Allen Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2018-11-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07610221013227 | K182838 | 000 |
| 07610221013210 | K182838 | 000 |
| 07610221013203 | K182838 | 000 |
| 07610221013197 | K182838 | 000 |
| 07610221013180 | K182838 | 000 |
| 07610221013173 | K182838 | 000 |
| 07610221013166 | K182838 | 000 |
Trademark Results [Geistlich Derma-Gide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GEISTLICH DERMA-GIDE 87778500 5555339 Live/Registered |
Geistlich Pharma AG 2018-01-31 |
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