The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for Medicotest Skin Fix.
Device ID | K926264 |
510k Number | K926264 |
Device Name: | MEDICOTEST SKIN FIX |
Classification | Tape And Bandage, Adhesive |
Applicant | MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
Contact | Randy R Mariani |
Correspondent | Randy R Mariani MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-18 |
Decision Date | 1993-04-20 |