510(k) K924503
K924503 is an FDA 510(k) premarket notification submitted by American Safety Razor Co. for the device "PERSONNA SAFETY SCALPEL". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. American Safety Razor Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1993
- Date Received
- September 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type