The following data is part of a premarket notification filed by Welmed Systems, Inc. with the FDA for Tracheostomy Care Tray.
| Device ID | K862663 |
| 510k Number | K862663 |
| Device Name: | TRACHEOSTOMY CARE TRAY |
| Classification | Tracheostomy And Nasal Suctioning Kit |
| Applicant | WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
| Contact | David B Peters |
| Correspondent | David B Peters WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
| Product Code | LRQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-07-30 |