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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diagnostic light, soft tissue detector
510(k) Number K151630
Device Name G.o.c.c.l.e.s.
Applicant
PIERREL PHARMA S.R.L.
STRADA STATALE APPIA 46/48
CAPUA,  IT 81043
Applicant Contact FABIO VELOTTI
Correspondent
ISEMED SRL
VIA A. BONETTI 3/A
IMOLA,  IT 40026
Correspondent Contact MAURIZIO PANTALEONI
Regulation Number872.6350
Classification Product Code
NXV  
Date Received06/17/2015
Decision Date 09/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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