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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Cast
510(k) Number K932507
Device Name QUICK-CAST IMMOBILIZER
Applicant
Landec Corp.
3603 Haven Ave.
Menlo Park,  CA  94025
Applicant Contact EDMUND F BYRNE
Correspondent
Landec Corp.
3603 Haven Ave.
Menlo Park,  CA  94025
Correspondent Contact EDMUND F BYRNE
Regulation Number888.5940
Classification Product Code
LGF  
Date Received05/25/1993
Decision Date 02/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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