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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Supplement, Culture Media
510(k) Number K861824
Device Name GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
Applicant
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Applicant Contact ROBERT BISHOP
Correspondent
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Correspondent Contact ROBERT BISHOP
Regulation Number866.2450
Classification Product Code
JSK  
Date Received05/12/1986
Decision Date 05/20/1986
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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