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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K914303
Device Name TARGET(TM)-HOG
Applicant
V-TECH, INC.
270 E. BONITA AVE.
POMONA,  CA  91767
Applicant Contact WILLA K BRUNKHORST
Correspondent
V-TECH, INC.
270 E. BONITA AVE.
POMONA,  CA  91767
Correspondent Contact WILLA K BRUNKHORST
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/25/1991
Decision Date 10/11/1991
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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