The following data is part of a premarket notification filed by Advanced Surgical Intervention, Inc. with the FDA for Urethral Dilator Endoscope.
| Device ID | K874530 |
| 510k Number | K874530 |
| Device Name: | URETHRAL DILATOR ENDOSCOPE |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Contact | Barry M Calvarese |
| Correspondent | Barry M Calvarese ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-03 |
| Decision Date | 1988-01-27 |