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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 K940798
Device Name SHIPPERT PRESSURE BANDAGE
Applicant
Denver Splint Co.
7002 S. Revere Pkwy.
Suite 60
Englewood,  CO  80112
Applicant Contact SARAH M LAKE
Correspondent
Denver Splint Co.
7002 S. Revere Pkwy.
Suite 60
Englewood,  CO  80112
Correspondent Contact SARAH M LAKE
Regulation Number880.5240
Classification Product Code
KGX  
Date Received02/22/1994
Decision Date 09/28/1994
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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