The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Swanson Titanium Carpal Lunate Implant.
Device ID | K864491 |
510k Number | K864491 |
Device Name: | SWANSON TITANIUM CARPAL LUNATE IMPLANT |
Classification | Prosthesis, Wrist, Carpal Lunate |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Anthony J Lentz |
Correspondent | Anthony J Lentz DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | KWN |
CFR Regulation Number | 888.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-13 |
Decision Date | 1987-04-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840420132802 | K864491 | 000 |
00840420129123 | K864491 | 000 |
00840420129116 | K864491 | 000 |
00840420129109 | K864491 | 000 |
00840420129093 | K864491 | 000 |