The following data is part of a premarket notification filed by Circon Acmi with the FDA for Circon Acmi Bicap Ii Therapeutic System Bc-200.
| Device ID | K884025 |
| 510k Number | K884025 |
| Device Name: | CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200 |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Contact | Taylor, P.e. |
| Correspondent | Taylor, P.e. CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-22 |
| Decision Date | 1989-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925008649 | K884025 | 000 |