The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Uhmwpe Components-change In Packaging.
Device ID | K940743 |
510k Number | K940743 |
Device Name: | UHMWPE COMPONENTS-CHANGE IN PACKAGING |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | David A Kotkovetz |
Correspondent | David A Kotkovetz DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Product Code | KWY |
Subsequent Product Code | HRY |
Subsequent Product Code | JDB |
Subsequent Product Code | KWI |
Subsequent Product Code | LZN |
CFR Regulation Number | 888.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-16 |
Decision Date | 1995-09-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295318088 | K940743 | 000 |
10603295318071 | K940743 | 000 |
10603295318064 | K940743 | 000 |