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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 K954533
Device Name ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION 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 Number880.6250
Classification Product Code
LZA  
Date Received09/29/1995
Decision Date 12/11/1995
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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