BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY


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

Correspodent Contact surender choudhry
Regulation Number 884.4530
Classification Product Code
HHT  
Date Received 05/30/2008
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