The following data is part of a premarket notification filed by Curamedical, Bv with the FDA for Gelita-spon Absorbable Gelatin Sponge, Usp.
| Device ID | K060878 |
| 510k Number | K060878 |
| Device Name: | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-31 |
| Decision Date | 2006-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860003109912 | K060878 | 000 |
| 00850056665018 | K060878 | 000 |
| 00860008294364 | K060878 | 000 |
| 00860008294371 | K060878 | 000 |
| 00860008294340 | K060878 | 000 |
| 00860003109977 | K060878 | 000 |
| 00860003109984 | K060878 | 000 |
| 00860003109991 | K060878 | 000 |
| 00860008294302 | K060878 | 000 |
| 04260293130075 | K060878 | 000 |
| 04260293130174 | K060878 | 000 |
| 04260293130068 | K060878 | 000 |
| 00860008294395 | K060878 | 000 |