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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K011497
Device Name CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
Applicant
Tillotson Healthcare Corp.
360 Route 101
Bedford,  NH  03110
Applicant Contact THOMAS N TILLOTSON
Correspondent
Tillotson Healthcare Corp.
360 Route 101
Bedford,  NH  03110
Correspondent Contact THOMAS N TILLOTSON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/15/2001
Decision Date 07/10/2001
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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