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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 Ave. Marcil
Montreal,  CA H4A 2Z3
Applicant Contact GUY FORTIER
Correspondent
Regen Lab SA
3428 Ave. Marcil
Montreal,  CA H4A 2Z3
Correspondent Contact GUY FORTIER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/17/2012
Decision Date 11/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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