The following data is part of a premarket notification filed by Scott Health Care with the FDA for Mefix(r) Adhesive Fabric For Dressing Fixation.
| Device ID | K932743 |
| 510k Number | K932743 |
| Device Name: | MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION |
| Classification | Tape And Bandage, Adhesive |
| Applicant | SCOTT HEALTH CARE P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Larry Bogart |
| Correspondent | Larry Bogart SCOTT HEALTH CARE P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1993-09-10 |