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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Sterilization
510(k) Number K951703
Device Name TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS
Applicant
Products For Medicine
3722 Ave. Sausalito
Irvine,  CA  92714
Applicant Contact GREG HOLLAND
Correspondent
Products For Medicine
3722 Ave. Sausalito
Irvine,  CA  92714
Correspondent Contact GREG HOLLAND
Regulation Number880.2800
Classification Product Code
LRT  
Date Received04/12/1995
Decision Date 06/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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