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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K984337
Device Name ELASTYLON POWDER-FREE SURGICAL GLOVE
Applicant
Eci Medical Technologies, Inc.
2 Cook Rd.
Bridgewater, Nova Scotia,  CA B4V 3W7
Applicant Contact STEPHEN L THOMPSON
Correspondent
Eci Medical Technologies, Inc.
2 Cook Rd.
Bridgewater, Nova Scotia,  CA B4V 3W7
Correspondent Contact STEPHEN L THOMPSON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/03/1998
Decision Date 04/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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