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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K880282
Device Name LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER
Applicant
Lima-Lto, Inc.
44 Amaral St.
East Providence,  RI  02915
Applicant Contact POLLOONIO-LISTER
Correspondent
Lima-Lto, Inc.
44 Amaral St.
East Providence,  RI  02915
Correspondent Contact POLLOONIO-LISTER
Regulation Number888.3040
Classification Product Code
JEC  
Date Received01/21/1988
Decision Date 02/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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