K932128 is an FDA 510(k) clearance for the CMI E-Z FLO BULB P.N. 701. This device is classified as a Adaptor, Bulbs, Miscellaneous, For Endoscope (Class I - General Controls, product code FFY).
Submitted by Columbia Medical & Surgical, Inc. (Bend, US). The FDA issued a Cleared decision on April 7, 1994, 339 days after receiving the submission on May 3, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K932128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1993 |
| Decision Date | April 07, 1994 |
| Days to Decision | 339 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FFY — Adaptor, Bulbs, Miscellaneous, For Endoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1500 |