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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K910963
Device Name THOROCENTESIS KIT
Applicant
MEGADYNE MEDICAL PRODUCTS, INC.
400 OSER AVE.
HAUPPAUGE,  NY  11788
Applicant Contact ELLEN JOY
Correspondent
MEGADYNE MEDICAL PRODUCTS, INC.
400 OSER AVE.
HAUPPAUGE,  NY  11788
Correspondent Contact ELLEN JOY
Regulation Number880.6740
Classification Product Code
JOL  
Date Received03/06/1991
Decision Date 06/20/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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