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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K994132
Device Name HARDYDISK IMIPENEM, 10MCG
Applicant
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Applicant Contact MELISSA M TRAYLOR
Correspondent
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Correspondent Contact MELISSA M TRAYLOR
Regulation Number866.1620
Classification Product Code
JTN  
Date Received12/07/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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