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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K922959
Device Name ISOPORE TAPE
Applicant
Lectec Corp.
10701 Red Circle Dr.
Minnetonka,  MN  55343
Applicant Contact CHAD MILLER
Correspondent
Lectec Corp.
10701 Red Circle Dr.
Minnetonka,  MN  55343
Correspondent Contact CHAD MILLER
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/18/1992
Decision Date 09/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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