PERSONNA DISPOSABLE SCALPEL

Blade, Scalpel

AMERICAN SAFETY RAZOR CO.

The following data is part of a premarket notification filed by American Safety Razor Co. with the FDA for Personna Disposable Scalpel.

Pre-market Notification Details

Device IDK873142
510k NumberK873142
Device Name:PERSONNA DISPOSABLE SCALPEL
ClassificationBlade, Scalpel
Applicant AMERICAN SAFETY RAZOR CO. P.O. BOX 500 Staunton,  VA  24401
ContactJane O Sawyer
CorrespondentJane O Sawyer
AMERICAN SAFETY RAZOR CO. P.O. BOX 500 Staunton,  VA  24401
Product CodeGES  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-10
Decision Date1987-09-04

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