The following data is part of a premarket notification filed by Spirit Ridge Technologies with the FDA for Prothesis, Chin, Internal.
Device ID | K952709 |
510k Number | K952709 |
Device Name: | PROTHESIS, CHIN, INTERNAL |
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 |