The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Ultra-fresh Deodorant.
Device ID | K871313 |
510k Number | K871313 |
Device Name: | ULTRA-FRESH DEODORANT |
Classification | Bag, Stomal |
Applicant | MENTOR CORP. 2700 FREEWAY BLVD. Minneapolis, MN 55430 |
Contact | David J Gamble |
Correspondent | David J Gamble MENTOR CORP. 2700 FREEWAY BLVD. Minneapolis, MN 55430 |
Product Code | GDS |
CFR Regulation Number | 876.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-01 |
Decision Date | 1988-03-02 |