The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Speedwrap, Dynawrap, Dynaplast Tape.
| Device ID | K903823 |
| 510k Number | K903823 |
| Device Name: | SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Contact | Gregory R Nelson |
| Correspondent | Gregory R Nelson SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1991-01-16 |