FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)
K Number: K963012
·
Decision Oct 15, 1996
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
9
Review Days
74
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Basic Information
- Device Name
- BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)
- K Number
- K963012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioject, Inc.
- Date Received
- August 2, 1996
- Decision Date
- October 15, 1996
- Product Code
- LHI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Bioject, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090003 | ZETAJET | Apr 2, 2009 | Substantially Equivalent |
| K050734 | COOL.CLICK | Jun 3, 2005 | Substantially Equivalent |
| K010623 | RECONSTITUTION KIT & VIAL CONNECTOR | Apr 5, 2001 | Substantially Equivalent |
| K003908 | SEROJET | Mar 8, 2001 | Substantially Equivalent |
| K994384 | CLICKER | Jun 22, 2000 | Substantially Equivalent |
| K960373 | BIOJECTOR 2000 MODEL 1B02000 | Mar 5, 1997 | Substantially Equivalent |
| K920631 | BIOJECT JET INJECTION SYSTEM | Jun 28, 1994 | Substantially Equivalent |
| K861687 | BIOJECTOR SYRINGE SYSTEM | Apr 23, 1987 | Substantially Equivalent |