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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Mechanical
510(k) Number K944307
Device Name JAMES LECKEY PRONE STANDER
Applicant
James Leckey Design
1250 Main St.
Waltham,  MA  02154
Applicant Contact JAMES J FALLS
Correspondent
James Leckey Design
1250 Main St.
Waltham,  MA  02154
Correspondent Contact JAMES J FALLS
Regulation Number890.3750
Classification Product Code
INW  
Date Received09/02/1994
Decision Date 12/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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