FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K Number: K901078
·
Decision May 18, 1990
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
127
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
- K Number
- K901078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- L H M Ent., Inc.
- Date Received
- March 7, 1990
- Decision Date
- May 18, 1990
- Product Code
- BTO
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTO), ordered by most recent decision date.
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
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FDA Class 2
·Anesthesiology
Pilling Tracheostomy Tubes
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FDA Class 2
·Anesthesiology
Venner PneuX TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX TT (Tracheostomy Tube) Size 9.0 mm
FDA 510(k)
FDA Class 2
·Anesthesiology
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
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FDA Class 2
·Anesthesiology
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
FDA 510(k)
FDA Class 2
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WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by L H M Ent., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901079 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER | May 18, 1990 | Substantially Equivalent |
| K894610 | CUSTOM TRAYS, KITS | Mar 15, 1990 | Unknown |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | Feb 15, 1990 | Substantially Equivalent |
| K894611 | CATHETER CARE KITS | Dec 15, 1989 | Unknown |
| K883506 | IRRIGATION KIT | Dec 13, 1988 | Substantially Equivalent |