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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K994148
Device Name 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
Applicant
Implant Innovations, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact WILLIAM G CONETY
Correspondent
Implant Innovations, Inc.
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact WILLIAM G CONETY
Regulation Number862.2050
Classification Product Code
JQC  
Date Received12/08/1999
Decision Date 02/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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