FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE
K Number: K963583
·
Decision Oct 7, 1996
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
12
Review Days
31
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Basic Information
- Device Name
- MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE
- K Number
- K963583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medimop Medical Projects, Ltd.
- Date Received
- September 6, 1996
- Decision Date
- October 7, 1996
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Medimop Medical Projects, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K160503 | Vented Vial Adapter Transfer Device - 13mm | May 4, 2016 | Substantially Equivalent |
| K140730 | VIAL2BAG DIRECT CONNECT | Jun 12, 2014 | Substantially Equivalent |
| K130179 | MP VIAL ADAPTER 13MM | Aug 8, 2013 | Substantially Equivalent |
| K132040 | VIAL CONNECTOR 13MM CLOSED COLLAR | Jul 31, 2013 | Substantially Equivalent |
| K122023 | MIXJECT WITH SPRAY HEAD | Oct 4, 2012 | Substantially Equivalent |
| K072511 | SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM | Dec 13, 2007 | Substantially Equivalent |
| K072759 | VIAL2BAG | Dec 13, 2007 | Substantially Equivalent |
| K062482 | VENTED VIAL ADAPTER TRANSFER DEVICE | Nov 3, 2006 | Substantially Equivalent |
| K031861 | MIX2VIAL TRANSFER DEVICE | Jul 29, 2003 | Substantially Equivalent |
| K001831 | NEEDLELESS TRANSFER DEVICE | Jul 11, 2000 | Substantially Equivalent |