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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K082676
Device Name GENADYNE A4 WOUND VACUUM SYSTEM
Applicant
GENADYNE BIOTECHNOLOGIES, INC.
65 WATERMILL LANE
GREAT NECK,  NY  11021
Applicant Contact CHIEN-MING GOH
Correspondent
GENADYNE BIOTECHNOLOGIES, INC.
65 WATERMILL LANE
GREAT NECK,  NY  11021
Correspondent Contact CHIEN-MING GOH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received09/15/2008
Decision Date 12/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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