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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 K941943
Device Name SURGICAL ADHESIVE TAPE
Applicant
Raleigh Lions Clinic For the Blind, Inc.
315 Hubert St.
Raleigh,  NC  27603
Applicant Contact JAMES W WELLS
Correspondent
Raleigh Lions Clinic For the Blind, Inc.
315 Hubert St.
Raleigh,  NC  27603
Correspondent Contact JAMES W WELLS
Regulation Number880.5240
Classification Product Code
KGX  
Date Received04/21/1994
Decision Date 06/30/1994
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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