510(k) K964634
K964634 is an FDA 510(k) premarket notification submitted by Mk Conquest Intl., Inc. for the device "ANOKRYO". The FDA issued a decision of Substantially Equivalent on June 6, 1997. The device falls under product code FFP (Dilator, Rectal), a Class I device regulated under 21 CFR 876.5450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1997
- Date Received
- November 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Rectal
- Device Class
- Class I
- Regulation Number
- 876.5450
- Review Panel
- GU
- Submission Type