The following data is part of a premarket notification filed by Spirit Ridge Technologies with the FDA for Pectoralis Implant.
| Device ID | K952708 |
| 510k Number | K952708 |
| Device Name: | PECTORALIS IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | SPIRIT RIDGE TECHNOLOGIES 19325 58TH PLANCE N.E. Seattle, WA 98155 |
| Contact | Kathty Richardson |
| Correspondent | Kathty Richardson SPIRIT RIDGE TECHNOLOGIES 19325 58TH PLANCE N.E. Seattle, WA 98155 |
| Product Code | FZE |
| Subsequent Product Code | FWP |
| Subsequent Product Code | LZK |
| Subsequent Product Code | MIB |
| Subsequent Product Code | MIC |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-14 |
| Decision Date | 1995-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724HTPI2R1 | K952708 | 000 |
| M724ACPI22R1 | K952708 | 000 |
| M724ACPI22L1 | K952708 | 000 |
| M724ACPI21R1 | K952708 | 000 |
| M724ACPI1L1 | K952708 | 000 |
| M724SGRTSPEC43L1 | K952708 | 000 |
| M724SGRTSPEC42R1 | K952708 | 000 |
| M724SGRTSPEC41R1 | K952708 | 000 |
| M724ACPI4L1 | K952708 | 000 |
| M724ACPI2L1 | K952708 | 000 |
| M724ACPI21L1 | K952708 | 000 |
| M724ACPI1R1 | K952708 | 000 |
| M724HTPI2RSIZNS1 | K952708 | 000 |
| M724ACPI23L1 | K952708 | 000 |
| M724ACPI23R1 | K952708 | 000 |
| M724HTPI2L1 | K952708 | 000 |
| M724SGRTSPEC44R1 | K952708 | 000 |
| M724SGRTSPEC44L1 | K952708 | 000 |
| M724SGRTSPEC43R1 | K952708 | 000 |
| M724SGRTSPEC42L1 | K952708 | 000 |
| M724SGRTSPEC41L1 | K952708 | 000 |
| M724BNPI1R1 | K952708 | 000 |
| M724BNPI1L1 | K952708 | 000 |
| M724ACPI4R1 | K952708 | 000 |
| M724ACPI3R1 | K952708 | 000 |
| M724ACPI3L1 | K952708 | 000 |
| M724ACPI2R1 | K952708 | 000 |
| M724HTPI2LSIZNS1 | K952708 | 000 |