The following data is part of a premarket notification filed by Circon Corp. with the FDA for Rigid Culdoscope And Accessories.
| Device ID | K980972 |
| 510k Number | K980972 |
| Device Name: | RIGID CULDOSCOPE AND ACCESSORIES |
| Classification | Culdoscope (and Accessories) |
| 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 | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925008915 | K980972 | 000 |
| 00821925002616 | K980972 | 000 |
| 00821925001527 | K980972 | 000 |