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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 K951705
Device Name MINISTRIP HCG
Applicant
International Newtech Development, Inc.
270-13500 Maycrest Way
Richmond, B.C.,  CA V6V 2N8
Applicant Contact JESSE ZHU
Correspondent
International Newtech Development, Inc.
270-13500 Maycrest Way
Richmond, B.C.,  CA V6V 2N8
Correspondent Contact JESSE ZHU
Regulation Number862.1155
Classification Product Code
JHI  
Date Received04/14/1995
Decision Date 10/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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