The following data is part of a premarket notification filed by Circon Corp. with the FDA for Circon Surgiflex Wave Tsunami Suction-irrigation System.
| Device ID | K992126 |
| 510k Number | K992126 |
| Device Name: | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | CIRCON CORP. 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen CIRCON CORP. 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-08-03 |
| Summary: | summary |