FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEEDLE, BLOOD COLLECTING
K Number: K790079
·
Decision Feb 1, 1979
Classifications
1
FEI Numbers
321
Registration Numbers
322
Same Product Code
106
Applicant Total
26
Review Days
23
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Basic Information
- Device Name
- NEEDLE, BLOOD COLLECTING
- K Number
- K790079
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Jelco Laboratories
- Date Received
- January 9, 1979
- Decision Date
- February 1, 1979
- Product Code
- GAA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Jelco Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | Oct 2, 1979 | Substantially Equivalent |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | Sep 12, 1979 | Substantially Equivalent |
| K790967 | CATHETER METAL HUB/RADIOPAQUE | Jun 27, 1979 | Substantially Equivalent |
| K790968 | CATHETER METAL HUB/NONRADIOPAQUE | Jun 11, 1979 | Substantially Equivalent |
| K790471 | JELCO* DISC FILTER-0.2 MICRON | Apr 30, 1979 | Substantially Equivalent |
| K790186 | PROTECTIVSTABILIZER | Feb 26, 1979 | Substantially Equivalent |
| K790107 | CATHETER TUBING MODIFICATION | Feb 1, 1979 | Substantially Equivalent |
| K781857 | TRAY, ARTERIAL BLOOD GAS SAMPLING | Dec 11, 1978 | Substantially Equivalent |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Aug 23, 1978 | Substantially Equivalent |
| K780519 | FILTER TUBE | May 9, 1978 | Substantially Equivalent |