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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Abortion, Vacuum
510(k) Number K850312
Device Name GYNASPYR VACUUM CURETTAGE UNIT
Applicant
ROSEBURG SA
1054 31ST STREET, N.W.
SUITE 120 CANAL SQUARE
WASHINGTON,  DC  20007
Applicant Contact CHAMBORD
Correspondent
ROSEBURG SA
1054 31ST STREET, N.W.
SUITE 120 CANAL SQUARE
WASHINGTON,  DC  20007
Correspondent Contact CHAMBORD
Regulation Number884.5070
Classification Product Code
HHI  
Date Received01/25/1985
Decision Date 02/28/1985
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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