The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for X-ray Detectable Cotton Balls.
| Device ID | K854714 |
| 510k Number | K854714 |
| Device Name: | X-RAY DETECTABLE COTTON BALLS |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | AMERICAN SILK SUTURES, INC. P.O. BOX 370 Ledyard, CT 06339 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-22 |
| Decision Date | 1985-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30749915000613 | K854714 | 000 |
| 20749915000548 | K854714 | 000 |
| 20749915000555 | K854714 | 000 |
| 20749915000562 | K854714 | 000 |
| 20749915000586 | K854714 | 000 |
| 20749915000593 | K854714 | 000 |
| 20749915000609 | K854714 | 000 |
| 20749915000623 | K854714 | 000 |
| 20749915000630 | K854714 | 000 |
| 20749915000647 | K854714 | 000 |
| 20749915000654 | K854714 | 000 |
| 20749915000661 | K854714 | 000 |
| 20749915000678 | K854714 | 000 |
| 20749915000685 | K854714 | 000 |
| 30749915000538 | K854714 | 000 |
| 20749915000517 | K854714 | 000 |