The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Modified Ultra-fresh Odor Reducing Compound.
Device ID | K883023 |
510k Number | K883023 |
Device Name: | MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND |
Classification | Bag, Stomal |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Lynn Breckenridge |
Correspondent | Lynn Breckenridge MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Product Code | GDS |
CFR Regulation Number | 876.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-19 |
Decision Date | 1988-09-29 |