510(k) K853103
K853103 is an FDA 510(k) premarket notification submitted by Medical Dimensions for the device "MCKNIFE". The FDA issued a decision of Substantially Equivalent on Aug 6, 1985. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Medical Dimensions has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 6, 1985
- Date Received
- Jul 23, 1985
- 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