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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name equipment, traction, powered
510(k) Number K981822
Device Name DRS SYSTEM
Applicant
PROFESSIONAL DISTRIBUTION SYSTEMS, INC.
1160 SOUTH ROGERS CIRCLE, #A
BOCA RATON,  FL  33487
Applicant Contact DAVID WILLIAMS
Correspondent
PROFESSIONAL DISTRIBUTION SYSTEMS, INC.
1160 SOUTH ROGERS CIRCLE, #A
BOCA RATON,  FL  33487
Correspondent Contact DAVID WILLIAMS
Regulation Number890.5900
Classification Product Code
ITH  
Date Received05/22/1998
Decision Date 06/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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