The following data is part of a premarket notification filed by Biological Resistance, Inc. with the FDA for Deodorizing And Sound Muffling Anal Pad.
| Device ID | K903342 |
| 510k Number | K903342 |
| Device Name: | DEODORIZING AND SOUND MUFFLING ANAL PAD |
| Classification | Garment, Protective, For Incontinence |
| Applicant | BIOLOGICAL RESISTANCE, INC. 70 ROPER RD. Princeton, NJ 08540 |
| Contact | Alexander Yabrov |
| Correspondent | Alexander Yabrov BIOLOGICAL RESISTANCE, INC. 70 ROPER RD. Princeton, NJ 08540 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-25 |
| Decision Date | 1990-10-23 |