The following data is part of a premarket notification filed by Circon Video with the FDA for Lowsley Suprapubic Tractor.
| Device ID | K012153 |
| 510k Number | K012153 |
| Device Name: | LOWSLEY SUPRAPUBIC TRACTOR |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Wayne B Stgrner |
| Correspondent | Wayne B Stgrner CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-11 |
| Decision Date | 2001-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925005204 | K012153 | 000 |
| 00821925005082 | K012153 | 000 |