FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
REUSABLE ALL - GLASS SYRINGES
K Number: K944542
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
1
Review Days
378
Basic Information
- Device Name
- REUSABLE ALL - GLASS SYRINGES
- K Number
- K944542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TOP SYRINGE MFG. CO.
- Date Received
- September 16, 1994
- Decision Date
- September 29, 1995
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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