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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 K860030
Device Name SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID
Applicant
Surgidyne, Inc.
9600 W. 76th St., Suite D
Eden Prairie,  MN  55344
Applicant Contact GEORGE L CARLSON
Correspondent
Surgidyne, Inc.
9600 W. 76th St., Suite D
Eden Prairie,  MN  55344
Correspondent Contact GEORGE L CARLSON
Regulation Number878.4780
Classification Product Code
BTA  
Date Received01/06/1986
Decision Date 02/12/1986
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
Predetermined Change
Control Plan Authorized		 No
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