510(k) K863950
K863950 is an FDA 510(k) premarket notification submitted by Precision Surgical Industries, Inc. for the device "P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL". The FDA issued a decision of Substantially Equivalent on Oct 24, 1986. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Precision Surgical Industries, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 24, 1986
- Date Received
- Oct 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Scalpel, One-Piece
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt