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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(K) Number K122122
Device Name REGEN SPRAY APPLICATOR,
Applicant
REGEN LAB SA
3428 avenue marcil
montreal, 
Contact guy fortier
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/15/2012
Decision Date 11/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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