The following data is part of a premarket notification filed by Circon Acmi with the FDA for Lap 3501 High Flow Insufflator.
| Device ID | K905705 |
| 510k Number | K905705 |
| Device Name: | LAP 3501 HIGH FLOW INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| Applicant | CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Contact | Ervin F Taylor |
| Correspondent | Ervin F Taylor CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, 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 | 1990-12-24 |
| Decision Date | 1991-02-28 |