K944051 is an FDA 510(k) clearance for the ABSORBALBE ANCHOR, a Strip, Dialysate Ph Indicator (Class II — Special Controls, product code MNV), submitted by Mitek Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on August 2, 1995, 348 days after receiving the submission on August 19, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K944051 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 19, 1994 |
| Decision Date | August 02, 1995 |
| Days to Decision | 348 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MNV — Strip, Dialysate Ph Indicator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |