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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K960213
Device Name CPR TOTAL HIP PACK
Applicant
Custom Pack Reliability
4207 Vineland Rd., M-1
Orlando,  FL  32811
Applicant Contact RICHARD L ELLWOOD
Correspondent
Custom Pack Reliability
4207 Vineland Rd., M-1
Orlando,  FL  32811
Correspondent Contact RICHARD L ELLWOOD
Regulation Number880.6850
Classification Product Code
FRG  
Date Received01/16/1996
Decision Date 04/12/1996
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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