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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, operating-room, ac-powered
510(k) Number K951854
Device Name LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY
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 Number878.4960
Classification Product Code
FQO  
Date Received04/21/1995
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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