FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROLLED NECK W/PLUG
K Number: K841411
·
Decision Apr 18, 1984
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
18
Applicant Total
15
Review Days
13
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Basic Information
- Device Name
- ROLLED NECK W/PLUG
- K Number
- K841411
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Warne Surgical Products, Ltd.
- Date Received
- April 5, 1984
- Decision Date
- April 18, 1984
- Product Code
- BTC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTC | Bag, Reservoir | FDA class 1 | Anesthesiology |
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Other Clearances by Warne Surgical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K850694 | WSP CODE 4310 STRESSCATH | May 17, 1985 | Substantially Equivalent |
| K850696 | WSP CODE 4300 DIOMASTER DIAGNOSTIC | 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 |
| K841412 | ROLLED NECK W/TAP | Apr 18, 1984 | Substantially Equivalent |
| K841409 | BUSH NECK W/PLUG | Apr 18, 1984 | Substantially Equivalent |
| K841410 | BUSH NECK W/TAP | Apr 18, 1984 | Substantially Equivalent |
| K840703 | SECURE W/30MM DIAM, SHEATH & ADHESIVE | Mar 22, 1984 | Substantially Equivalent |