510(k) K861804
K861804 is an FDA 510(k) premarket notification submitted by Medcomp Technologies, Inc. for the device "MEDCARE SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent on May 23, 1986. 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