FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYRINGE NEEDLE INTRODUCER
K Number: K901803
·
Decision Nov 20, 1990
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
4
Review Days
215
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Basic Information
- Device Name
- SYRINGE NEEDLE INTRODUCER
- K Number
- K901803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Glaxo, Inc.
- Date Received
- April 19, 1990
- Decision Date
- November 20, 1990
- 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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