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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 K023658
Device Name STERILIZATION CASES AND TRAYS
Applicant
Carr Metal Products, Inc.
6329 W. Waterview Court
Mccordsville,  IN  46055 -9501
Applicant Contact PAUL DRYDEN
Correspondent
Carr Metal Products, Inc.
6329 W. Waterview Court
Mccordsville,  IN  46055 -9501
Correspondent Contact PAUL DRYDEN
Regulation Number880.6850
Classification Product Code
FRG  
Date Received10/31/2002
Decision Date 03/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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