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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K792471
Device Name STANFORD STERILE LAP SPONGES
Applicant
Lukens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Lukens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4450
Classification Product Code
GDY  
Date Received12/03/1979
Decision Date 12/20/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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