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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 K971044
Device Name DASH, SULLIVAN, VITAL GARD
Applicant
Dash Medical Gloves, Inc.
10180 S. 54th St.
Franklin,  WI  53132
Applicant Contact ROBERT J SULLIVAN JR.
Correspondent
Dash Medical Gloves, Inc.
10180 S. 54th St.
Franklin,  WI  53132
Correspondent Contact ROBERT J SULLIVAN JR.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/21/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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