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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, sponge, surgical
510(k) Number K790538
Device Name SPONGE COUNTER
Applicant
DEVON INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DEVON INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.2740
Classification Product Code
LWH  
Date Received03/20/1979
Decision Date 04/04/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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