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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 K000745
Device Name SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Applicant
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Applicant Contact THOMAS N TILLOTSON
Correspondent
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Correspondent Contact THOMAS N TILLOTSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/08/2000
Decision Date 05/03/2000
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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