FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVOLET
K Number: K080665
·
Decision May 13, 2008
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- NOVOLET
- K Number
- K080665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- U.S. Safety Syringes Co., Inc.
- Date Received
- March 10, 2008
- Decision Date
- May 13, 2008
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by U.S. Safety Syringes Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090502 | NOVA SAFE SCALP VEIN BLOOD COLLECTION SET | Mar 10, 2009 | Substantially Equivalent |
| K090122 | NUOVOGUARD | Feb 5, 2009 | Substantially Equivalent |
| K083454 | NUOVOCATH | Dec 4, 2008 | Substantially Equivalent |
| K080660 | IV ADMINISTRATION SET | May 13, 2008 | Substantially Equivalent |
| K003381 | SHIELDING NEEDLE HOLDER | Apr 23, 2001 | Substantially Equivalent |
| K990831 | SUPERGUARD SAFETY SYRINGE | Mar 8, 2000 | Substantially Equivalent |