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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 K911327
Device Name CELL SWEEP
Applicant
Reza S Mohajer, M.D. C/O Krass & Young
C/O Krass & Young Law Offices
3001 W. Big Beaver Rd. Suite 624
Troy,  MI  48084
Applicant Contact RONALD W CITKOWSKI
Correspondent
Reza S Mohajer, M.D. C/O Krass & Young
C/O Krass & Young Law Offices
3001 W. Big Beaver Rd. Suite 624
Troy,  MI  48084
Correspondent Contact RONALD W CITKOWSKI
Regulation Number884.4530
Classification Product Code
HHT  
Date Received03/26/1991
Decision Date 05/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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