FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASD SINGLE LUMEN NEEDLE
K Number: K884620
·
Decision Nov 21, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
17
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Basic Information
- Device Name
- ASD SINGLE LUMEN NEEDLE
- K Number
- K884620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Biosurge, Inc.
- Date Received
- November 4, 1988
- Decision Date
- November 21, 1988
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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