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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Gas Generating
510(k) Number K862123
Device Name BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
Applicant
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Applicant Contact WILLIAM H GUINTY,JR
Correspondent
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Correspondent Contact WILLIAM H GUINTY,JR
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received06/03/1986
Decision Date 06/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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