K964634 is an FDA 510(k) clearance for the ANOKRYO, a Dilator, Rectal (Class I — General Controls, product code FFP), submitted by Mk Conquest Intl., Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 6, 1997, 199 days after receiving the submission on November 19, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5450.
| 510(k) Number | K964634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 1996 |
| Decision Date | June 06, 1997 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFP — Dilator, Rectal |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.5450 |