510(k) K873142

PERSONNA DISPOSABLE SCALPEL by American Safety Razor Co. — Product Code GES

K873142 is an FDA 510(k) premarket notification submitted by American Safety Razor Co. for the device "PERSONNA DISPOSABLE SCALPEL". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code GES (Blade, Scalpel), 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
September 4, 1987
Date Received
August 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type