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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 K012230
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 Received07/16/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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