The following data is part of a premarket notification filed by Nitto Denko America, Inc. with the FDA for Nitto Surgical Non-woven Tape St-320.
| Device ID | K853646 |
| 510k Number | K853646 |
| Device Name: | NITTO SURGICAL NON-WOVEN TAPE ST-320 |
| Classification | Tape And Bandage, Adhesive |
| Applicant | NITTO DENKO AMERICA, INC. SAN FRANCISCO BRANCH 2900 CORVIN DRIVE Santa Clara, CA 95051 |
| Contact | Kogami |
| Correspondent | Kogami NITTO DENKO AMERICA, INC. SAN FRANCISCO BRANCH 2900 CORVIN DRIVE Santa Clara, CA 95051 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1985-09-19 |