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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spatula, cervical, cytological
510(k) Number K081522
Device Name BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
Applicant
BIO NUCLEAR DIAGNOSTICS, INC.
1791 ALBION RD.
TORONTO, ONTARIO,  CA M9W 5S7
Applicant Contact SURENDER CHOUDHRY
Correspondent
BIO NUCLEAR DIAGNOSTICS, INC.
1791 ALBION RD.
TORONTO, ONTARIO,  CA M9W 5S7
Correspondent Contact SURENDER CHOUDHRY
Regulation Number884.4530
Classification Product Code
HHT  
Date Received05/30/2008
Decision Date 12/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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