FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUSH NECK W/PLUG
K Number: K841409
·
Decision Apr 18, 1984
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
8
Applicant Total
15
Review Days
13
Basic Information
- Device Name
- BUSH NECK W/PLUG
- K Number
- K841409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- WARNE SURGICAL PRODUCTS, LTD.
- Date Received
- April 5, 1984
- Decision Date
- April 18, 1984
- Product Code
- BYZ
- 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 |
|---|---|---|---|
| BYZ | Trap, Sterile Specimen | FDA class 2 | General Hospital |
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Other Clearances by WARNE SURGICAL PRODUCTS, LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K850696 | WSP CODE 4300 DIOMASTER DIAGNOSTIC | May 17, 1985 | Substantially Equivalent |
| K850694 | WSP CODE 4310 STRESSCATH | May 17, 1985 | Substantially Equivalent |
| K850695 | WSP CODE 4301 DIOMASTER THERAPEUTIC | May 16, 1985 | Substantially Equivalent |
| K850693 | WSP CODE 4315 PADTEST | May 10, 1985 | Substantially Equivalent |
| K841511 | HAEMATURIA CATHETERS | Jul 12, 1984 | Substantially Equivalent |
| K840687 | KIDNEY TRANSPLANT CATHETER | Jun 7, 1984 | Substantially Equivalent |
| K841410 | BUSH NECK W/TAP | Apr 18, 1984 | Substantially Equivalent |
| K841411 | ROLLED NECK W/PLUG | Apr 18, 1984 | Substantially Equivalent |
| K841412 | ROLLED NECK W/TAP | Apr 18, 1984 | Substantially Equivalent |
| K840703 | SECURE W/30MM DIAM, SHEATH & ADHESIVE | Mar 22, 1984 | Substantially Equivalent |