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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K930028
Device Name CALMPS: BONE, MASTIN, LEWIN, BRAND
Applicant
Thomasville Medical Assoc.
1100-B Cambridge Sq.
Alpharetta,  GA  30201
Applicant Contact THOMAS J ZINNANTI
Correspondent
Thomasville Medical Assoc.
1100-B Cambridge Sq.
Alpharetta,  GA  30201
Correspondent Contact THOMAS J ZINNANTI
Regulation Number888.4540
Classification Product Code
LXH  
Date Received01/05/1993
Decision Date 02/16/1993
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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