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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Bite
510(k) Number K896745
Device Name JAW BLOCKER
Applicant
Plastic Engineered Products Co.
800 Savannah Ave. NE
Canton,  OH  44704
Applicant Contact P THOMPSON
Correspondent
Plastic Engineered Products Co.
800 Savannah Ave. NE
Canton,  OH  44704
Correspondent Contact P THOMPSON
Regulation Number882.5070
Classification Product Code
JXL  
Date Received11/30/1989
Decision Date 12/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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