The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Dermistick Sepp Applicator(200 Ct)/(40 Ct) 260640/260641.
Device ID | K962740 |
510k Number | K962740 |
Device Name: | DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 |
Classification | Bandage, Liquid |
Applicant | MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso, TX 79906 |
Contact | Thomas Vanne |
Correspondent | Thomas Vanne MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso, TX 79906 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-15 |
Decision Date | 1996-09-06 |