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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K940035
Device Name KIT,I.V. START
Applicant
Mason-Keller Corp.
119 Harrison Ave.
Roseland,  NJ  07068
Applicant Contact ALFRED C CAGGIA
Correspondent
Mason-Keller Corp.
119 Harrison Ave.
Roseland,  NJ  07068
Correspondent Contact ALFRED C CAGGIA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/04/1994
Decision Date 06/03/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
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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