The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Meniscus Chin Implant.
Device ID | K944164 |
510k Number | K944164 |
Device Name: | MENISCUS CHIN IMPLANT |
Classification | Implant, Malar |
Applicant | SPECTRUM DESIGNS, INC. 5921-C MATTHEWS ST. Goleta, CA 93117 |
Contact | Jim Dishman |
Correspondent | Jim Dishman SPECTRUM DESIGNS, INC. 5921-C MATTHEWS ST. Goleta, CA 93117 |
Product Code | LZK |
Subsequent Product Code | FWP |
Subsequent Product Code | FZE |
CFR Regulation Number | 878.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-26 |
Decision Date | 1994-11-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M724250144S1 | K944164 | 000 |
M724250134S1 | K944164 | 000 |
M724250124S1 | K944164 | 000 |
M724250114S1 | K944164 | 000 |
M7249000011 | K944164 | 000 |