The following data is part of a premarket notification filed by American Cystocope Makers, Inc. with the FDA for Acmi Rigi-flex Nephorscope.
| Device ID | K791182 |
| 510k Number | K791182 |
| Device Name: | ACMI RIGI-FLEX NEPHORSCOPE |
| Classification | Kit, Nephroscope |
| Applicant | AMERICAN CYSTOCOPE MAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FGA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-25 |
| Decision Date | 1979-07-30 |