510(k) K790534
K790534 is an FDA 510(k) premarket notification submitted by Hancock Laboratories, Inc. for the device "MERSILENE SUTURES". The FDA issued a decision of Substantially Equivalent on March 26, 1979. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Hancock Laboratories, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1979
- Date Received
- March 13, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Annuloplasty
- Device Class
- Class II
- Regulation Number
- 870.3800
- Review Panel
- CV
- Submission Type