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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 K993835
Device Name PARAPOST SYSTEM STERILIZABLE ORGANIZER
Applicant
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430 -2009
Applicant Contact H.J. VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430 -2009
Correspondent Contact H.J. VOGELSTEIN
Regulation Number880.6850
Classification Product Code
FRG  
Date Received11/12/1999
Decision Date 12/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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