FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AUTOJECT 2 FOR GLASSY SYRINGE
K Number: K122837
·
Decision Oct 15, 2012
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
13
Review Days
28
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Basic Information
- Device Name
- AUTOJECT 2 FOR GLASSY SYRINGE
- K Number
- K122837
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owen Mumford, Ltd.
- Date Received
- September 17, 2012
- Decision Date
- October 15, 2012
- Product Code
- KZH
- 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 |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
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