The following data is part of a premarket notification filed by Urology Research Intl., Inc. with the FDA for Besecure External Urinary Collection System.
| Device ID | K971271 |
| 510k Number | K971271 |
| Device Name: | BESECURE EXTERNAL URINARY COLLECTION SYSTEM |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | UROLOGY RESEARCH INTL., INC. P.O. BOX 02544 Cleveland, OH 44102 |
| Contact | Frank A Manfredi |
| Correspondent | Frank A Manfredi UROLOGY RESEARCH INTL., INC. P.O. BOX 02544 Cleveland, OH 44102 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-04 |
| Decision Date | 1997-08-18 |