The following data is part of a premarket notification filed by Circon Acmi with the FDA for Circon Acmi Bicap Hemorrhoid System Bh-10 & Bhp-20.
| Device ID | K884252 |
| 510k Number | K884252 |
| Device Name: | CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20 |
| 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 | 1988-10-11 |
| Decision Date | 1989-01-10 |