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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K843000
Device Name MICRO ORGANISM GROWTH SYS-M1000
Applicant
Hml Inc/Biotechnology Transfer
950 Kings Hwy. North
Cherry Hill,  NJ  08034
Applicant Contact JULIUS J JABLONSKY
Correspondent
Hml Inc/Biotechnology Transfer
950 Kings Hwy. North
Cherry Hill,  NJ  08034
Correspondent Contact JULIUS J JABLONSKY
Regulation Number866.2900
Classification Product Code
LIO  
Date Received07/30/1984
Decision Date 02/06/1985
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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