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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 K970015
Device Name ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
Applicant
Eci Medical Technologies, Inc.
2 Cook Rd.
Bridgewater, Nova Scotia,  CA B4V 3W7
Applicant Contact MICHAEL FORER
Correspondent
Eci Medical Technologies, Inc.
2 Cook Rd.
Bridgewater, Nova Scotia,  CA B4V 3W7
Correspondent Contact MICHAEL FORER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/02/1997
Decision Date 06/24/1997
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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