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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K955528
Device Name CLP BONNET
Applicant
Clp Products
502 Teak Dr.
Lake Park,  FL  33403
Applicant Contact WILLIAM P MCNEER III
Correspondent
Clp Products
502 Teak Dr.
Lake Park,  FL  33403
Correspondent Contact WILLIAM P MCNEER III
Regulation Number872.5500
Classification Product Code
DZB  
Date Received12/04/1995
Decision Date 02/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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