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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 K952335
Device Name WOUND CARE MANAGEMENT KITS
Applicant
Continental Medical Laboratories, Inc.
P.O. Box 306
817 Mohr Ave.
Waterford,  WI  53185
Applicant Contact JOSEPH DUNN
Correspondent
Continental Medical Laboratories, Inc.
P.O. Box 306
817 Mohr Ave.
Waterford,  WI  53185
Correspondent Contact JOSEPH DUNN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/18/1995
Decision Date 06/14/1995
Decision Substantially Equivalent (SESE)
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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