The following data is part of a premarket notification filed by Walling Medical Equipment Co. with the FDA for Reliant Constriction Ring.
| Device ID | K940995 |
| 510k Number | K940995 |
| Device Name: | RELIANT CONSTRICTION RING |
| Classification | Device, External Penile Rigidity |
| Applicant | WALLING MEDICAL EQUIPMENT CO. 3000 CANDIDE LN. Mckinney, TX 75070 |
| Contact | Allan Walling |
| Correspondent | Allan Walling WALLING MEDICAL EQUIPMENT CO. 3000 CANDIDE LN. Mckinney, TX 75070 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-04 |
| Decision Date | 1994-06-14 |