The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Titanium Wire.
Device ID | K041333 |
510k Number | K041333 |
Device Name: | SYNTHES (USA) TITANIUM WIRE |
Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Lisa M Boyle |
Correspondent | Lisa M Boyle SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | GAQ |
CFR Regulation Number | 878.4495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-19 |
Decision Date | 2004-08-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H98049310301S0 | K041333 | 000 |
H98049310201S0 | K041333 | 000 |
H98049310101S0 | K041333 | 000 |
10887587056166 | K041333 | 000 |