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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Manual
510(k) Number K922366
Device Name SPINE LINE
Applicant
Dambrecine, Inc.
10151 University Blvd.,
Suite 237
Orlando,  FL  32817
Applicant Contact MICHAEL DAMBRO
Correspondent
Dambrecine, Inc.
10151 University Blvd.,
Suite 237
Orlando,  FL  32817
Correspondent Contact MICHAEL DAMBRO
Regulation Number890.5660
Classification Product Code
LYG  
Date Received05/20/1992
Decision Date 07/13/1992
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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