The following data is part of a premarket notification filed by Mk Conquest Intl., Inc. with the FDA for Anokryo.
| Device ID | K964634 |
| 510k Number | K964634 |
| Device Name: | ANOKRYO |
| Classification | Dilator, Rectal |
| Applicant | MK CONQUEST INTL., INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer MK CONQUEST INTL., INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Product Code | FFP |
| CFR Regulation Number | 876.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-19 |
| Decision Date | 1997-06-06 |
| Summary: | summary |