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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 -2392
Applicant Contact JAMES W WELLS
Correspondent
RALEIGH LIONS CLINIC FOR THE BLIND, INC.
315 HUBERT ST.
RALEIGH,  NC  27603 -2392
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
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