The following data is part of a premarket notification filed by Manner Medical Products with the FDA for Cannulae, Plastic Disposable Nasal.
Device ID | K760218 |
510k Number | K760218 |
Device Name: | CANNULAE, PLASTIC DISPOSABLE NASAL |
Classification | Cannula, Nasal, Oxygen |
Applicant | MANNER MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAT |
CFR Regulation Number | 868.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-12 |
Decision Date | 1976-08-03 |