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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
510(k) Number K896801
Device Name LAP SPONGE
Applicant
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Applicant Contact SURY SHONEY
Correspondent
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Correspondent Contact SURY SHONEY
Classification Product Code
EFQ  
Date Received12/01/1989
Decision Date 12/27/1989
Decision Substantially Equivalent (SESE)
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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