The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Ready Nurse System (rns) Trach Care Kit.
Device ID | K952925 |
510k Number | K952925 |
Device Name: | READY NURSE SYSTEM (RNS) TRACH CARE KIT |
Classification | Tracheostomy And Nasal Suctioning Kit |
Applicant | CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
Contact | Scott Williams |
Correspondent | Scott Williams CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
Product Code | LRQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-26 |
Decision Date | 1995-07-12 |