The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Sterile Suprafoil Smooth Nylon Foil Sheets.
| Device ID | K973379 |
| 510k Number | K973379 |
| Device Name: | STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS |
| Classification | Mesh, Surgical |
| Applicant | S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303 |
| Contact | J. Jackson |
| Correspondent | J. Jackson S. JACKSON, INC. 15 ROTH ST. P.O. BOX 4487 Alexandria, VA 22303 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1997-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816848023913 | K973379 | 000 |
| 10816848023746 | K973379 | 000 |
| 10816848022923 | K973379 | 000 |
| 10816848022909 | K973379 | 000 |