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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Powered
510(k) Number K933622
Device Name FLEXION DISTRACTION TABLE
Applicant
Spinalight, Inc.
320 A Bell Park Dr.
Woodstock,  GA  30188
Applicant Contact MARTIN CIROU
Correspondent
Spinalight, Inc.
320 A Bell Park Dr.
Woodstock,  GA  30188
Correspondent Contact MARTIN CIROU
Regulation Number890.3760
Classification Product Code
INQ  
Date Received07/19/1993
Decision Date 01/07/1994
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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