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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K883125
Device Name CASF STERILIZATION TRAY
Applicant
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Applicant Contact JUDY WILSON
Correspondent
Terray Manufacturing, Inc.
24 Mcgonigal St. W.
Arnprior
Ontario K7s 1l8,  CA
Correspondent Contact JUDY WILSON
Regulation Number878.4800
Classification Product Code
FSM  
Date Received07/26/1988
Decision Date 08/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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