The following data is part of a premarket notification filed by Uni-patch, Inc. with the FDA for Conduct Aloe Gel, #up239-8fl. Oz/#up245 G-1 Gallon.
Device ID | K925466 |
510k Number | K925466 |
Device Name: | CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON |
Classification | Media, Electroconductive |
Applicant | UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. Wabasha, MN 55981 -0271 |
Contact | Alan I Becker |
Correspondent | Alan I Becker UNI-PATCH, INC. P.O. BOX 271 1313 WEST GRANT BLVD. Wabasha, MN 55981 -0271 |
Product Code | GYB |
CFR Regulation Number | 882.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-29 |
Decision Date | 1993-08-26 |