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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K882938
Device Name STAT FAX(TM)
Applicant
Awareness Technology, Inc.
P.O. Drawer 1679
3481 SW Palm City School Rd.
Palm City,  FL  34990
Applicant Contact MARY FREEMAN
Correspondent
Awareness Technology, Inc.
P.O. Drawer 1679
3481 SW Palm City School Rd.
Palm City,  FL  34990
Correspondent Contact MARY FREEMAN
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/13/1988
Decision Date 09/09/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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