The following data is part of a premarket notification filed by American Cystocope Makers, Inc. with the FDA for Air Water Source (acmi Model 710).
| Device ID | K760451 |
| 510k Number | K760451 |
| Device Name: | AIR WATER SOURCE (ACMI MODEL 710) |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | AMERICAN CYSTOCOPE MAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-16 |
| Decision Date | 1976-08-30 |