510(k) K863557
K863557 is an FDA 510(k) premarket notification submitted by American Safety Razor Co. for the device "BLADE, SURGICAL PREPARATION RAZOR, STRAIGHT,SINGLE". The FDA issued a decision of Substantially Equivalent on October 6, 1986. American Safety Razor Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1986
- Date Received
- September 12, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No