FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPO(R) SAFETY CARTRIDGE SYRINGE
K Number: K936040
·
Decision May 1, 1995
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
163
Applicant Total
423
Review Days
497
Basic Information
- Device Name
- HYPO(R) SAFETY CARTRIDGE SYRINGE
- K Number
- K936040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SMITH & NEPHEW, INC.
- Date Received
- December 20, 1993
- Decision Date
- May 1, 1995
- Product Code
- MEG
- 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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