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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 K042580
Device Name TIDI BRAND STERILIZATION WRAP
Applicant
Banta Healthcare Group, Ltd.
2454 Mcmullen Booth Rd.
Clearwater,  FL  33759
Applicant Contact INA GORDON
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/22/2004
Decision Date 11/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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