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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Facial, Mandibular Implant
510(k) Number K901923
Device Name INVOTEC POLY-MESH MANDIBULAR TRAY
Applicant
Invotec International, Inc.
11330-1st. John'S Industrial
Pkwy.
Jacksonville,  FL  32216
Applicant Contact JEFFREY L AULL
Correspondent
Invotec International, Inc.
11330-1st. John'S Industrial
Pkwy.
Jacksonville,  FL  32216
Correspondent Contact JEFFREY L AULL
Regulation Number874.3695
Classification Product Code
JAZ  
Date Received04/30/1990
Decision Date 10/31/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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