The following data is part of a premarket notification filed by Scott Health Care with the FDA for Mepore (6x7).
Device ID | K954274 |
510k Number | K954274 |
Device Name: | MEPORE (6X7) |
Classification | Bandage, Liquid |
Applicant | SCOTT HEALTH CARE 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
Contact | Richard A Hammer |
Correspondent | Richard A Hammer SCOTT HEALTH CARE 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-13 |
Decision Date | 1995-12-19 |