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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Yeast
510(k) Number K900112
Device Name MICRORING YT
Applicant
Medical Wire & Equipment Co.
4053 W. 214th. St.
Fairview Park,  OH  44126
Applicant Contact KAESTLE MT
Correspondent
Medical Wire & Equipment Co.
4053 W. 214th. St.
Fairview Park,  OH  44126
Correspondent Contact KAESTLE MT
Regulation Number866.2660
Classification Product Code
JXB  
Date Received01/09/1990
Decision Date 07/31/1990
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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