510(k) K851516
K851516 is an FDA 510(k) premarket notification submitted by Cher Mel Corp. for the device "CHERMEL SCALP VEIN SET". The FDA issued a decision of Substantially Equivalent on August 23, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cher Mel Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1985
- Date Received
- April 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type