The following data is part of a premarket notification filed by Rocky Mountain Medical Corp. with the FDA for Prefer Incontinence Aid.
| Device ID | K851876 |
| 510k Number | K851876 |
| Device Name: | PREFER INCONTINENCE AID |
| Classification | Garment, Protective, For Incontinence |
| Applicant | ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Contact | RICHARD J ROSENBAUM |
| Correspondent | RICHARD J ROSENBAUM ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Product Code | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-29 |
| Decision Date | 1985-06-12 |