TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1
FDA 510(k) clearance K871692 · decided 1987-06-01
Clearance details
- K-number
- K871692
- Device name
- TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1
- Applicant
- Automatic Liquid Packaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-29
- Decision date
- 1987-06-01
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- LRQ
- Device class
- 1
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Woodstock, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Automatic Liquid Packaging
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 CARE TRAY (K862663) | Welmed Systems, Inc. | 1986-07-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STERILE SALINE PRESERVED SOLUTION (P850070/S010) | Automatic Liquid Packaging, Inc. | 1997-07-02 |
| STERILE SALINE PRESERVED SOLUTION (P850070/S009) | Automatic Liquid Packaging, Inc. | 1997-06-20 |
| STERILE SALINE PRESERVED SOLUTION (P850070/S008) | Automatic Liquid Packaging, Inc. | 1996-07-10 |
| STERILE UNPRESERVED SALINE SOLUTION (P850070/S006) | Automatic Liquid Packaging, Inc. | 1990-11-05 |
| STERILE UNPRESERVED SALINE SOLUTION (P850070/S005) | Automatic Liquid Packaging, Inc. | 1990-06-22 |
| 4 OZ. STERILE UNPRESERVED SALINE SOLUTION (P850070/S004) | Automatic Liquid Packaging, Inc. | 1990-03-15 |
| STERICON SALINE SOLUTION (P850070/S003) | Automatic Liquid Packaging, Inc. | 1989-09-18 |
| STERICON SALINE SOLUTION (P850070/S002) | Automatic Liquid Packaging, Inc. | 1987-12-29 |