The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for Strung Telfa Non-adherent Sponge.
| Device ID | K904514 |
| 510k Number | K904514 |
| Device Name: | STRUNG TELFA NON-ADHERENT SPONGE |
| Classification | Neurosurgical Paddie |
| Applicant | AMERICAN SILK SUTURES, INC. 8433 N.W. 78 COURT Tamarac, FL 33321 |
| Contact | Win Hirsch |
| Correspondent | Win Hirsch AMERICAN SILK SUTURES, INC. 8433 N.W. 78 COURT Tamarac, FL 33321 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1991-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00749915002555 | K904514 | 000 |
| 20749915001682 | K904514 | 000 |
| 20749915001699 | K904514 | 000 |
| 20749915001705 | K904514 | 000 |
| 20749915001729 | K904514 | 000 |
| 20749915001743 | K904514 | 000 |
| 20749915001774 | K904514 | 000 |
| 20749915001798 | K904514 | 000 |
| 20749915001804 | K904514 | 000 |
| 20749915001811 | K904514 | 000 |
| 20749915001828 | K904514 | 000 |
| 20749915001835 | K904514 | 000 |
| 30749915001764 | K904514 | 000 |
| 20749915001675 | K904514 | 000 |