The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for Non-woven Tracheotomy Sponge.
| Device ID | K872807 |
| 510k Number | K872807 |
| Device Name: | NON-WOVEN TRACHEOTOMY SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | AMERICAN SILK SUTURES, INC. 57 MUNROE ST. Lynn, MA 01901 |
| Contact | Ed Greenspan |
| Correspondent | Ed Greenspan AMERICAN SILK SUTURES, INC. 57 MUNROE ST. Lynn, MA 01901 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-08-04 |