The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Curity Catheter Plug With Protective Cap.
Device ID | K951488 |
510k Number | K951488 |
Device Name: | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP |
Classification | Accessories, Catheter, G-u |
Applicant | THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
Contact | Paul W Evans |
Correspondent | Paul W Evans THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
Product Code | KNY |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-31 |
Decision Date | 1995-04-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521007816 | K951488 | 000 |