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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852180
Device Name SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.
Applicant
Surgidyne, Inc.
6975 Washington Ave.
Suite 200
Minneapolis,  MN  55435
Applicant Contact GEORGE L CARLSON
Correspondent
Surgidyne, Inc.
6975 Washington Ave.
Suite 200
Minneapolis,  MN  55435
Correspondent Contact GEORGE L CARLSON
Date Received05/20/1985
Decision Date 07/01/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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