The following data is part of a premarket notification filed by Albert K. Chin with the FDA for Prosthetic Cement Remover.
Device ID | K890285 |
510k Number | K890285 |
Device Name: | PROSTHETIC CEMENT REMOVER |
Classification | System, Cement Removal Extraction |
Applicant | ALBERT K. CHIN 3274 ALPINE RD. Portola Valley, CA 94025 |
Contact | Chin, M.d. |
Correspondent | Chin, M.d. ALBERT K. CHIN 3274 ALPINE RD. Portola Valley, CA 94025 |
Product Code | LZV |
CFR Regulation Number | 888.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-19 |
Decision Date | 1989-04-19 |