FDA 510(k)
FDA class 2
Substantially Equivalent
🇵🇱 Poland
DropSafe Safety Pen Needle
K Number: K170988
·
Decision Dec 12, 2017
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
7
Review Days
253
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Basic Information
- Device Name
- DropSafe Safety Pen Needle
- K Number
- K170988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Htl-Strefa S.A
- Date Received
- April 3, 2017
- Decision Date
- December 12, 2017
- 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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| K202340 | Droplet Pen Needle 30G & 33G | Oct 15, 2020 | Substantially Equivalent |
| K192082 | Droplet Pen Needle 34G | Apr 21, 2020 | Substantially Equivalent |
| K171982 | DROPLET PEN NEEDLE | Mar 21, 2018 | Substantially Equivalent |
| K143437 | Droplet Pen Needles | Jun 25, 2015 | Substantially Equivalent |