The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Dover Silver Temperature Sensing Foley Catheter.
Device ID | K042709 |
510k Number | K042709 |
Device Name: | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER |
Classification | Catheter, Retention Type, Balloon |
Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Contact | Wei Zhao |
Correspondent | Wei Zhao TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Product Code | EZL |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2004-09-30 |
Decision Date | 2005-01-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521149236 | K042709 | 000 |
10884521149229 | K042709 | 000 |