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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, Non-Propagating Transport
510(k) Number K935987
Device Name FLEXTRANS
Applicant
Baxter Diagnostics, Inc.
2005 NW Sammamish Rd.
Issaquash,  WA  98027
Applicant Contact NANCY MALLINAK
Correspondent
Baxter Diagnostics, Inc.
2005 NW Sammamish Rd.
Issaquash,  WA  98027
Correspondent Contact NANCY MALLINAK
Regulation Number866.2390
Classification Product Code
JSM  
Date Received12/14/1993
Decision Date 08/15/1994
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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