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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 K032161
Device Name PHEM-ALERT
Applicant
FEMTEK,LLC.
11605 HITCHING POST LN.
ROCKVILLE,  MD  20852
Applicant Contact JOEL S FADEN
Correspondent
FEMTEK,LLC.
11605 HITCHING POST LN.
ROCKVILLE,  MD  20852
Correspondent Contact JOEL S FADEN
Regulation Number862.1550
Classification Product Code
LNW  
Date Received07/15/2003
Decision Date 09/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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