510(k) K861806
K861806 is an FDA 510(k) premarket notification submitted by Medcomp Technologies, Inc. for the device "MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)". The FDA issued a decision of Substantially Equivalent on May 23, 1986. The device falls under product code KDA (Prosthesis, Ptfe/Carbon-Fiber), a Class II device regulated under 21 CFR 878.3500. Medcomp Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1986
- Date Received
- May 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Ptfe/Carbon-Fiber
- Device Class
- Class II
- Regulation Number
- 878.3500
- Review Panel
- SU
- Submission Type