The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Dyna-flex Multi-layer Compression System.
| Device ID | K970721 |
| 510k Number | K970721 |
| Device Name: | DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM |
| Classification | Wound Dressing Kit |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 2500 E. ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Contact | William P Robb |
| Correspondent | William P Robb JOHNSON & JOHNSON MEDICAL, INC. 2500 E. ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-27 |
| Decision Date | 1997-03-21 |
| Summary: | summary |