The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for Medcare Tracheostomy Care Tray.
Device ID | K961167 |
510k Number | K961167 |
Device Name: | MEDCARE TRACHEOSTOMY CARE TRAY |
Classification | Tracheostomy And Nasal Suctioning Kit |
Applicant | MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
Contact | Craig J Bell |
Correspondent | Craig J Bell MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
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 | 1996-03-25 |
Decision Date | 1996-07-02 |
Summary: | summary |