The following data is part of a premarket notification filed by Advanced Care Medical Products with the FDA for Vented External Male Urinary Catheter(vented Cath 5000).
| Device ID | K972100 |
| 510k Number | K972100 |
| Device Name: | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) |
| Classification | Device, Incontinence, Urosheath Type, Sterile |
| Applicant | ADVANCED CARE MEDICAL PRODUCTS 385 BEL MARIN KEYS BLVD. #J Novato, CA 94949 |
| Contact | Steven Fainsztein |
| Correspondent | Steven Fainsztein ADVANCED CARE MEDICAL PRODUCTS 385 BEL MARIN KEYS BLVD. #J Novato, CA 94949 |
| Product Code | EXJ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-04 |
| Decision Date | 1997-07-31 |