The following data is part of a premarket notification filed by Buffalo Medical Specialties Mfg., Inc. with the FDA for External Male Catheter.
| Device ID | K852051 |
| 510k Number | K852051 |
| Device Name: | EXTERNAL MALE CATHETER |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | BUFFALO MEDICAL SPECIALTIES MFG., INC. P.O. BOX 17247 14205 MYER LAKE CIRCLE Clearwater, FL 33520 |
| Contact | Hansen |
| Correspondent | Hansen BUFFALO MEDICAL SPECIALTIES MFG., INC. P.O. BOX 17247 14205 MYER LAKE CIRCLE Clearwater, FL 33520 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-08-22 |