TRACHEOSTOMY CARE TRAY
FDA 510(k) clearance K862663 · decided 1986-07-30
Clearance details
- K-number
- K862663
- Device name
- TRACHEOSTOMY CARE TRAY
- Applicant
- Welmed Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-14
- Decision date
- 1986-07-30
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LRQ
- Device class
- 1
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- West Swanzey, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRACHEOSTOMY KIT (K963720) | Grand Medical Products | 1996-11-27 |
| MEDCARE TRACHEOSTOMY CARE TRAY (K961167) | Medcare Medical Group, Inc. | 1996-07-02 |
| READY NURSE SYSTEM (RNS) TRACH CARE KIT (K952925) | Contour Fabricators of Florida, Inc. | 1995-07-12 |
| GENT-L-KARE TRACHEOSTOMY TRAYS (K950851) | Premium Plastics, Inc. | 1995-06-21 |
| TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 (K871692) | Automatic Liquid Packaging, Inc. | 1987-06-01 |
Recalls involving this device
No recalls on record reference this clearance.