510(k) K071823

Device
PERMA FACIAL IMPLANTS
Applicant
SURGISIL
510(k) number
K071823
Product code
ODU  
Decision
Substantially Equivalent (SESE)
Decision date
2007-09-19
Date received
2007-07-03
Regulation
878.3500
Classification name
Facial Implant
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CYNTHIA J NOLTE
Address
49 Plain St. North Attleboro MA US 02760 02760

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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