FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMSINO TRACHEOSTOMY CARE TRAY
K Number: K023276
·
Decision Dec 9, 2002
Classifications
1
FEI Numbers
165
Registration Numbers
165
Same Product Code
109
Applicant Total
17
Review Days
69
Basic Information
- Device Name
- AMSINO TRACHEOSTOMY CARE TRAY
- K Number
- K023276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AMSINO INTERNATIONAL, INC.
- Date Received
- October 1, 2002
- Decision Date
- December 9, 2002
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by AMSINO INTERNATIONAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K101958 | AMSINO I.V. ADMINISTRATION AND EXTENSION SETS | Sep 29, 2010 | Substantially Equivalent |
| K101824 | AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER | Sep 13, 2010 | Substantially Equivalent |
| K093773 | AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS | Mar 10, 2010 | Substantially Equivalent |
| K091306 | AMSURE PVC INTERMITTENT CATHETER | Aug 21, 2009 | Substantially Equivalent |
| K091699 | AMSURE HYDROPHILIC LATEX FOLEY CATHETER | Aug 10, 2009 | Substantially Equivalent |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | Oct 23, 2008 | Substantially Equivalent |
| K070411 | AMSURE NEBULIZER | Oct 1, 2007 | Substantially Equivalent |
| K061039 | AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE | Jun 29, 2006 | Substantially Equivalent |
| K050785 | AMSINO ENDOTRACHEAL TUBE | Jul 15, 2005 | Substantially Equivalent |
| K051059 | AMSURE 100% SILICONE FOLEY CATHETER | Jun 28, 2005 | Substantially Equivalent |