The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Curity Oxygen Nasal Cannula.
Device ID | K892435 |
510k Number | K892435 |
Device Name: | KENDALL CURITY OXYGEN NASAL CANNULA |
Classification | Cannula, Nasal, Oxygen |
Applicant | THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
Contact | William D Curtin |
Correspondent | William D Curtin THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
Product Code | CAT |
CFR Regulation Number | 868.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1989-06-12 |