The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Neuflex Pip Finger.
Device ID | K001922 |
510k Number | K001922 |
Device Name: | DEPUY NEUFLEX PIP FINGER |
Classification | Prosthesis, Finger, Constrained, Polymer |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Janet G Johnson |
Correspondent | Janet G Johnson DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Product Code | KYJ |
CFR Regulation Number | 888.3230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-23 |
Decision Date | 2000-08-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295017936 | K001922 | 000 |
10603295017929 | K001922 | 000 |
10603295017912 | K001922 | 000 |
10603295017905 | K001922 | 000 |
10603295017899 | K001922 | 000 |