FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Safe'n'Sound Staked Passive Delivery System - Plajex version
K Number: K150562
·
Decision Jun 2, 2015
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- Safe'n'Sound Staked Passive Delivery System - Plajex version
- K Number
- K150562
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nemera
- Date Received
- March 6, 2015
- Decision Date
- June 2, 2015
- 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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