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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Selective And Non-Differential
510(k) Number K850969
Device Name INHIBITORY MOLD AGAR PLATE
Applicant
Granite Diagnostics, Inc.
1308 Rainey St.
Burlington,  NC  27215
Applicant Contact DAVID PRESTON
Correspondent
Granite Diagnostics, Inc.
1308 Rainey St.
Burlington,  NC  27215
Correspondent Contact DAVID PRESTON
Regulation Number866.2360
Classification Product Code
JSJ  
Date Received03/08/1985
Decision Date 03/29/1985
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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