510(k) K924503

PERSONNA SAFETY SCALPEL by American Safety Razor Co. — Product Code MDM

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