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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852976
Device Name NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC
Applicant
American Micro Scan
855 57th. St. Suite G
Sacramento,  CA  95819
Applicant Contact ALICE J O'CONNELL
Correspondent
American Micro Scan
855 57th. St. Suite G
Sacramento,  CA  95819
Correspondent Contact ALICE J O'CONNELL
Date Received07/15/1985
Decision Date 12/04/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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