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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adsorbents, Ion-Exchange
510(k) Number K873932
Device Name THE EXTRACTOR(TM)
Applicant
Molecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego,  CA  92121
Applicant Contact PETER WESTKAEMPER
Correspondent
Molecular Biosystems, Inc.
10030 Barnes Canyon Rd.
San Diego,  CA  92121
Correspondent Contact PETER WESTKAEMPER
Regulation Number862.2230
Classification Product Code
DKO  
Date Received09/25/1987
Decision Date 11/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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