PARAMETRIC STERILITY RELEASE OF AUTO

Stapler, Surgical

UNITED SURGICAL CORP.

The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Parametric Sterility Release Of Auto.

Pre-market Notification Details

Device IDK830741
510k NumberK830741
Device Name:PARAMETRIC STERILITY RELEASE OF AUTO
ClassificationStapler, Surgical
Applicant UNITED SURGICAL CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGAG  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-08
Decision Date1983-08-11

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