FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HESUNG'S HYPERDERMIC NEEDLES
K Number: K841565
·
Decision Jul 17, 1984
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
91
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Basic Information
- Device Name
- HESUNG'S HYPERDERMIC NEEDLES
- K Number
- K841565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Amkor Trading Co.
- Date Received
- April 17, 1984
- Decision Date
- July 17, 1984
- 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 Amkor Trading Co.
| K Number | Device Name | ||
|---|---|---|---|
| K841561 | HESUNG'S BLOOD DONOR SETS | Aug 30, 1984 | Substantially Equivalent |
| K841562 | HESUNG BLOOD TRANSFUSION SETS | Jul 23, 1984 | Substantially Equivalent |
| K841564 | HESUNG SCALP VEIN SET | Jul 17, 1984 | Substantially Equivalent |
| K841563 | HESUNG'S SOLUTION INFUSION SETS | Jul 17, 1984 | Substantially Equivalent |
| K841566 | HESUNG DISPOSABLE SYRINGE | Jul 17, 1984 | Substantially Equivalent |