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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863194
Device Name TENDERM TAPE
Applicant
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Applicant Contact ROLF, PH.D.
Correspondent
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Correspondent Contact ROLF, PH.D.
Date Received08/19/1986
Decision Date 09/30/1986
Decision Substantially Equivalent (SESE)
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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