The following data is part of a premarket notification filed by Spirit Ridge Technologies with the FDA for Spirit Ridge Silicone Carving Block.
| Device ID | K952706 |
| 510k Number | K952706 |
| Device Name: | SPIRIT RIDGE SILICONE CARVING BLOCK |
| Classification | Prosthesis, Nose, Internal |
| Applicant | SPIRIT RIDGE TECHNOLOGIES 19325 58TH PLANCE N.E. Seattle, WA 98155 |
| Contact | Kathy Richardson |
| Correspondent | Kathy 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 |
|---|---|---|
| M724CCB841 | K952706 | 000 |
| M724CCB851 | K952706 | 000 |
| M724CCB821 | K952706 | 000 |
| M724CCB421 | K952706 | 000 |
| M724CCB411 | K952706 | 000 |
| M724CCB341 | K952706 | 000 |
| M724CCB231 | K952706 | 000 |
| M724CCB111 | K952706 | 000 |
| M724CCB82SIZNS1 | K952706 | 000 |
| M724CCB81SIZNS1 | K952706 | 000 |
| M724CCB34SIZNS1 | K952706 | 000 |
| M724BL20OSNS1 | K952706 | 000 |
| M724BL20OMNS1 | K952706 | 000 |
| M724CCB121 | K952706 | 000 |
| M724CCB131 | K952706 | 000 |
| M724CCB831 | K952706 | 000 |
| M724CCB811 | K952706 | 000 |
| M724CCB451 | K952706 | 000 |
| M724CCB441 | K952706 | 000 |
| M724CCB431 | K952706 | 000 |
| M724CCB331 | K952706 | 000 |
| M724CCB321 | K952706 | 000 |
| M724CCB311 | K952706 | 000 |
| M724CCB221 | K952706 | 000 |
| M724CCB211 | K952706 | 000 |
| M724CCB151 | K952706 | 000 |
| M724CCB141 | K952706 | 000 |
| M724BL20OFNS1 | K952706 | 000 |