The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for American Nasal Sponge.
| Device ID | K872905 |
| 510k Number | K872905 |
| Device Name: | AMERICAN NASAL SPONGE |
| Classification | Splint, Nasal |
| 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 | EPP |
| CFR Regulation Number | 874.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-24 |
| Decision Date | 1987-09-04 |