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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K960514
Device Name TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)
Applicant
Anspach Fixation Systems
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact WILLIAM E ANSPACH
Correspondent
Anspach Fixation Systems
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact WILLIAM E ANSPACH
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/25/1996
Decision Date 04/15/1996
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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