The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Ceramic Femoral Head.
Device ID | K893685 |
510k Number | K893685 |
Device Name: | CERAMIC FEMORAL HEAD |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Diane Deere |
Correspondent | Diane Deere DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-16 |
Decision Date | 1989-09-26 |