The following data is part of a premarket notification filed by Curamedical, Bv with the FDA for Gelita-spon.
| Device ID | K051911 |
| 510k Number | K051911 |
| Device Name: | GELITA-SPON |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | CURAMEDICAL, BV 220 RIVER ROAD Claremont, NH 03743 |
| Contact | William Greenrose |
| Correspondent | William Greenrose CURAMEDICAL, BV 220 RIVER ROAD Claremont, NH 03743 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-14 |
| Decision Date | 2005-12-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GELITA-SPON 79021991 3256631 Live/Registered |
GELITA Health GmbH 2006-03-07 |