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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K914478
Device Name NSN #6545-00-656-1093 KIT, FIRST AID
Applicant
Cooperative Workshops, Inc.
1500 Ewing Dr.
P.O. Box 1565
Sedalia,  MO  65301
Applicant Contact JOHN D CHAMBERS
Correspondent
Cooperative Workshops, Inc.
1500 Ewing Dr.
P.O. Box 1565
Sedalia,  MO  65301
Correspondent Contact JOHN D CHAMBERS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/08/1991
Decision Date 01/06/1992
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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