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#
Legacy Summary#
summary
FDA Review#
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