FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Sungshim Insulin Pen Needle
K Number: K152334
·
Decision Mar 17, 2016
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
2
Review Days
211
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Basic Information
- Device Name
- Sungshim Insulin Pen Needle
- K Number
- K152334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sung Shim Medicare Co., Ltd.
- Date Received
- August 19, 2015
- Decision Date
- March 17, 2016
- 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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Other Clearances by Sung Shim Medicare Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K152803 | SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE | Jul 12, 2016 | Substantially Equivalent |