K936311 is an FDA 510(k) clearance for the MITEK MINI ANCHOR. This device is classified as a Strip, Dialysate Ph Indicator (Class II - Special Controls, product code MNV).
Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on October 31, 1995, 559 days after receiving the submission on April 20, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K936311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | April 20, 1994 |
| Decision Date | October 31, 1995 |
| Days to Decision | 559 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | MNV — Strip, Dialysate Ph Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |