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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name paper, obstetric ph
510(k) Number K960648
Device Name PHEM-CHEK
Applicant
FEMTEK, INC.
50 BELLEFONTAINE ST.
PASADENA,  CA  91105 -3181
Applicant Contact JAMES C CAILLOUETTE, MD
Correspondent
FEMTEK, INC.
50 BELLEFONTAINE ST.
PASADENA,  CA  91105 -3181
Correspondent Contact JAMES C CAILLOUETTE, MD
Regulation Number862.1550
Classification Product Code
LNW  
Date Received02/14/1996
Decision Date 05/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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