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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K940069
Device Name DRESSING CHANGE KIT
Applicant
Mason-Keller Corp.
119 Harrison Ave.
Roseland,  NJ  07068
Applicant Contact ALFRED R CAGGIA
Correspondent
Mason-Keller Corp.
119 Harrison Ave.
Roseland,  NJ  07068
Correspondent Contact ALFRED R CAGGIA
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Code
LRO  
Date Received01/06/1994
Decision Date 03/18/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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