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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K883582
Device Name VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM
Applicant
SURGIDYNE, INC.
9600 W. 76TH STREET, SUITE D
EDEN PRAIRIE,  MN  55344
Applicant Contact MARY M MAIJER
Correspondent
SURGIDYNE, INC.
9600 W. 76TH STREET, SUITE D
EDEN PRAIRIE,  MN  55344
Correspondent Contact MARY M MAIJER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received08/22/1988
Decision Date 10/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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