The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc ("stl") with the FDA for Pureform Eptfe Facial Implants (nasal, Chin, Maler).
| Device ID | K091011 |
| 510k Number | K091011 |
| Device Name: | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) |
| Classification | Prosthesis, Chin, Internal |
| Applicant | SURGICAL TECHNOLOGY LABORATORIES, INC ("STL") 610 CLEMSON ROAD Columbia, SC 29229 |
| Contact | Mathew Fairfax |
| Correspondent | Mathew Fairfax SURGICAL TECHNOLOGY LABORATORIES, INC ("STL") 610 CLEMSON ROAD Columbia, SC 29229 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-09 |
| Decision Date | 2009-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850987007307 | K091011 | 000 |
| 00850987007123 | K091011 | 000 |
| 00850987007116 | K091011 | 000 |
| 00850987007109 | K091011 | 000 |
| 00850987007093 | K091011 | 000 |
| 00850987007086 | K091011 | 000 |
| 00850987007079 | K091011 | 000 |
| 00850987007062 | K091011 | 000 |
| 00850987007055 | K091011 | 000 |
| 00850987007048 | K091011 | 000 |
| 00850987007031 | K091011 | 000 |
| 00850987007024 | K091011 | 000 |
| 00850987007017 | K091011 | 000 |
| 00850987007000 | K091011 | 000 |
| 00854804007082 | K091011 | 000 |
| 00854804007075 | K091011 | 000 |
| 00850987007130 | K091011 | 000 |
| 00850987007147 | K091011 | 000 |
| 00850987007291 | K091011 | 000 |
| 00850987007284 | K091011 | 000 |
| 00850987007277 | K091011 | 000 |
| 00850987007260 | K091011 | 000 |
| 00850987007253 | K091011 | 000 |
| 00850987007246 | K091011 | 000 |
| 00850987007239 | K091011 | 000 |
| 00850987007222 | K091011 | 000 |
| 00850987007215 | K091011 | 000 |
| 00850987007208 | K091011 | 000 |
| 00850987007192 | K091011 | 000 |
| 00850987007185 | K091011 | 000 |
| 00850987007178 | K091011 | 000 |
| 00850987007161 | K091011 | 000 |
| 00850987007154 | K091011 | 000 |
| 00854804007068 | K091011 | 000 |