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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 K944560
Device Name MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
Applicant
KLS-Martin L.P.
Regulatory Consultant
2550 M St., NW
Washington,  DC  20037
Applicant Contact MARK A HELLER
Correspondent
KLS-Martin L.P.
Regulatory Consultant
2550 M St., NW
Washington,  DC  20037
Correspondent Contact MARK A HELLER
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/16/1994
Decision Date 10/18/1994
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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