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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K841275
Device Name FINE NEEDLE ASPIRATION DEVICE
Applicant
GYNECO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GYNECO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.5200
Classification Product Code
DRM  
Date Received03/27/1984
Decision Date 08/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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