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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solvent, adhesive tape
510(k) Number K924571
Device Name MEDI-SOL
Applicant
ORANGE-SOL, INC.
955 N. FIESTA BLVD., STE. #1
GILBERT,  AZ  85234
Applicant Contact GURNEY
Correspondent
ORANGE-SOL, INC.
955 N. FIESTA BLVD., STE. #1
GILBERT,  AZ  85234
Correspondent Contact GURNEY
Regulation Number878.4730
Classification Product Code
KOX  
Date Received09/10/1992
Decision Date 04/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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