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510(k) K161507

Device
Cianna Medical SAVI Scout Reflector And SAVI Scout System
Applicant
CIANNA MEDICAL, INC.
510(k) number
K161507
Product code
PDW  
Decision
Substantially Equivalent (SESE)
Decision date
2016-07-29
Date received
2016-06-01
Regulation
878.4670
Classification name
Internal Tissue Marker
Medical specialty
General & Plastic Surgery
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GARY MOCNIK
Address
6 Journey, Suite 125 Aliso Viejo CA US 92656 92656

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PDW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN130004MOERAE SURGICAL MARKING PENMoerae Matrix, Inc.2014-12-18
K141318CIANNA MEDICAL SGS SYSTEMCianna Medical, Inc.2014-08-27

Legacy Summary#

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FDA Review#

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