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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 K945833
Device Name ELASTYREN(R) SURGICAL GLOVES
Applicant
Eci Medical Technologies, Inc.
44 E. Beaver Creek Rd.
Bldg. 5
Richmondhill, Ontario,  CA L4B 1G8
Applicant Contact MICHAEL FORER
Correspondent
Eci Medical Technologies, Inc.
44 E. Beaver Creek Rd.
Bldg. 5
Richmondhill, Ontario,  CA L4B 1G8
Correspondent Contact MICHAEL FORER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/29/1994
Decision Date 01/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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