FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPODERMIC NEEDLES, SINGLE LUMEN
K Number: K874414
·
Decision Jan 14, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
7
Review Days
78
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Basic Information
- Device Name
- HYPODERMIC NEEDLES, SINGLE LUMEN
- K Number
- K874414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Harbor Medical Devices, Inc.
- Date Received
- October 28, 1987
- Decision Date
- January 14, 1988
- 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 Harbor Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884628 | HARBORIN CENTRAL VENOUS CATHETER | May 15, 1989 | Substantially Equivalent |
| K890518 | SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM | Apr 21, 1989 | Substantially Equivalent |
| K882657 | HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT | Dec 13, 1988 | Substantially Equivalent |
| K881884 | HARBOR CENTRAL VENOUS CATHETER | Jul 28, 1988 | Substantially Equivalent |
| K882190 | S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM | Jun 9, 1988 | Substantially Equivalent |
| K880297 | SEA - PORT INFUSION SET | Feb 19, 1988 | Substantially Equivalent |