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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K930313
Device Name APEX SPECIMEN BAG
Applicant
Apex Medical Technologies, Inc.
10064 Mesa Ridge Ct., #202
San Diego,  CA  92121
Applicant Contact STEFANIE KRAMER
Correspondent
Apex Medical Technologies, Inc.
10064 Mesa Ridge Ct., #202
San Diego,  CA  92121
Correspondent Contact STEFANIE KRAMER
Regulation Number866.2900
Classification Product Code
LIO  
Date Received01/22/1993
Decision Date 03/18/1993
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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