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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Label Or Tag, Sterile
510(k) Number K884055
Device Name SURGI-TAG(TM) STERILE LABEL SETS
Applicant
Acacia Laboratories, Inc.
1010 Hathaway Ave.
Santa Ana,  CA  92705
Applicant Contact A GOOLSBEE
Correspondent
Acacia Laboratories, Inc.
1010 Hathaway Ave.
Santa Ana,  CA  92705
Correspondent Contact A GOOLSBEE
Regulation Number878.4800
Classification Product Code
LYV  
Date Received09/26/1988
Decision Date 10/13/1988
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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