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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stapler, surgical
510(k) Number K830741
Device Name PARAMETRIC STERILITY RELEASE OF AUTO
Applicant
UNITED SURGICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
UNITED SURGICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4740
Classification Product Code
GAG  
Date Received03/08/1983
Decision Date 08/11/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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