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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name marker, skin
510(k) Number K896792
Device Name SURGICAL SKIN MARKER
Applicant
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Applicant Contact SURY SHONEY
Correspondent
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Correspondent Contact SURY SHONEY
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received12/01/1989
Decision Date 12/27/1989
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
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