The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Lundeen Subtalar Peg Implant.
| Device ID | K922292 |
| 510k Number | K922292 |
| Device Name: | LUNDEEN SUBTALAR PEG IMPLANT |
| Classification | Prosthesis, Subtalar, Plug, Polymer |
| Applicant | SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
| Contact | Thomas E Sgarlato |
| Correspondent | Thomas E Sgarlato SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
| Product Code | MJW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1992-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852164007995 | K922292 | 000 |
| 00819034029549 | K922292 | 000 |
| 00819034029532 | K922292 | 000 |
| 00819034029525 | K922292 | 000 |
| 00819034029518 | K922292 | 000 |
| 00819034029501 | K922292 | 000 |
| 00819034029495 | K922292 | 000 |
| 00819034029488 | K922292 | 000 |
| 00819034029471 | K922292 | 000 |
| 00819034029464 | K922292 | 000 |
| 00819034029457 | K922292 | 000 |
| 00819034029440 | K922292 | 000 |
| 00819034029556 | K922292 | 000 |
| 00819034029303 | K922292 | 000 |
| 00819034029310 | K922292 | 000 |
| 00819034029426 | K922292 | 000 |
| 00819034029419 | K922292 | 000 |
| 00819034029402 | K922292 | 000 |
| 00819034029396 | K922292 | 000 |
| 00819034029389 | K922292 | 000 |
| 00819034029372 | K922292 | 000 |
| 00819034029365 | K922292 | 000 |
| 00819034029358 | K922292 | 000 |
| 00819034029341 | K922292 | 000 |
| 00819034029334 | K922292 | 000 |
| 00819034029327 | K922292 | 000 |
| 00819034029433 | K922292 | 000 |