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FDA 510(k) Application Details - K030060
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
510(K) Number
K030060
Device Name
Equipment, Traction, Powered
Applicant
CERT HEALTH SCIENCES, LLC
203 MAIN ST.
PMB 166
FLEMINGTON, NJ 08822 US
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Contact
LYNETTE HOWARD
Other 510(k) Applications for this Contact
Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2003
Decision Date
02/05/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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