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 |