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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 K972047
Device Name KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
Applicant
KLS-MARTIN L.P.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Applicant Contact ED RANSOM
Correspondent
KLS-MARTIN L.P.
40178 U.S. 19 NORTH
TARPON SPRINGS,  FL  34689
Correspondent Contact ED RANSOM
Regulation Number872.4760
Classification Product Code
MQN  
Date Received06/02/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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