The following data is part of a premarket notification filed by Circon Video with the FDA for Circon Acmi Cat.# Lap 9900; High Flow Insufflator.
| Device ID | K914101 |
| 510k Number | K914101 |
| Device Name: | CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, CT 06904 -1971 |
| Contact | Ervin F Taylor |
| Correspondent | Ervin F Taylor CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, CT 06904 -1971 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-12 |
| Decision Date | 1991-11-22 |