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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K912684
Device Name HOME MEDICAL KIT - FOR LITTLE HURTS
Applicant
GREAT WEST MEDICAL EQUIPMENT, INC.
2081 ESQUIMALT AVENUE
WEST VANCOUVER, B.C.,  CA V7V 1S3
Applicant Contact MASON C KENT
Correspondent
GREAT WEST MEDICAL EQUIPMENT, INC.
2081 ESQUIMALT AVENUE
WEST VANCOUVER, B.C.,  CA V7V 1S3
Correspondent Contact MASON C KENT
Regulation Number880.5075
Classification Product Code
MCY  
Date Received06/14/1991
Decision Date 10/15/1991
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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