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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clinical Sample Concentrator
510(k) Number K871290
Device Name CENTRICELL(TM)
Applicant
Polysciences, Inc.
400 Valley Rd.
Warrington,  PA  18976
Applicant Contact MICHAEL H OTT
Correspondent
Polysciences, Inc.
400 Valley Rd.
Warrington,  PA  18976
Correspondent Contact MICHAEL H OTT
Regulation Number862.2310
Classification Product Code
JJH  
Date Received03/31/1987
Decision Date 08/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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