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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mandibular Fixator And/Or Distractor
510(k) Number K993869
Device Name INTER-OS BONE GENERATOR
Applicant
INTER-OS TECHNOLOGIES, L.L.C.
7144 S. CHAPPARAL CIR. E.
AURORA,  CO  80016
Applicant Contact RANDOLPH C ROBINSON
Correspondent
INTER-OS TECHNOLOGIES, L.L.C.
7144 S. CHAPPARAL CIR. E.
AURORA,  CO  80016
Correspondent Contact RANDOLPH C ROBINSON
Regulation Number872.4760
Classification Product Code
MQN  
Date Received11/15/1999
Decision Date 01/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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