The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Nasal Cannula, With And Without Supply Tubing, And Other Similar Nasal Cannula Manufactured By Hrci.
| Device ID | K011125 |
| 510k Number | K011125 |
| Device Name: | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI |
| Classification | Cannula, Nasal, Oxygen |
| Applicant | HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Contact | Jeannie L Denning |
| Correspondent | Jeannie L Denning HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Product Code | CAT |
| CFR Regulation Number | 868.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-06-13 |