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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K895685
Device Name SMALL JOINT HAND INSTRUMENTS
Applicant
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Applicant Contact LEONARD J BONNELL
Correspondent
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Correspondent Contact LEONARD J BONNELL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/22/1989
Decision Date 10/16/1989
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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