The following data is part of a premarket notification filed by Surgisil with the FDA for Perma Facial Implants.
| Device ID | K071823 |
| 510k Number | K071823 |
| Device Name: | PERMA FACIAL IMPLANTS |
| Classification | Facial Implant |
| Applicant | SURGISIL 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte SURGISIL 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | ODU |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853437006080 | K071823 | 000 |
| 00853437006066 | K071823 | 000 |
| 00853437006059 | K071823 | 000 |
| 00853437006042 | K071823 | 000 |
| 00853437006035 | K071823 | 000 |
| 00853437006028 | K071823 | 000 |
| 00853437006011 | K071823 | 000 |
| 00853437006004 | K071823 | 000 |