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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Reservoir
510(k) Number K864822
Device Name VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
Applicant
SURGIDYNE, INC.
9600 W. 76TH STREET, SUITE D
EDEN PRAIRIE,  MN  55344
Applicant Contact JUD CARLSON
Correspondent
SURGIDYNE, INC.
9600 W. 76TH STREET, SUITE D
EDEN PRAIRIE,  MN  55344
Correspondent Contact JUD CARLSON
Regulation Number868.5320
Classification Product Code
BTC  
Date Received12/09/1986
Decision Date 01/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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