The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for Polyester Sponge Pattie.
| Device ID | K862494 |
| 510k Number | K862494 |
| Device Name: | POLYESTER SPONGE PATTIE |
| Classification | Neurosurgical Paddie |
| Applicant | AMERICAN SILK SUTURES, INC. 91 NASON RD. Swampscott, MA 01907 |
| Contact | Ed Greenspan |
| Correspondent | Ed Greenspan AMERICAN SILK SUTURES, INC. 91 NASON RD. Swampscott, MA 01907 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-07-30 |