The following data is part of a premarket notification filed by Circon Video with the FDA for Circon Endotek Om-4 H2o Cystometry Pump.
| Device ID | K970595 |
| 510k Number | K970595 |
| Device Name: | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk CIRCON VIDEO 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-10-24 |
| Summary: | summary |