The following data is part of a premarket notification filed by American Cystocope Makers, Inc. with the FDA for Acmi Aspirator Kit #8808.
| Device ID | K811218 |
| 510k Number | K811218 |
| Device Name: | ACMI ASPIRATOR KIT #8808 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | AMERICAN CYSTOCOPE MAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-07-01 |