FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
K Number: K041691
·
Decision Aug 5, 2004
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
6
Review Days
44
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Basic Information
- Device Name
- CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
- K Number
- K041691
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- West Pharmaceutical Services, Inc.
- Date Received
- June 22, 2004
- Decision Date
- August 5, 2004
- 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 West Pharmaceutical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | May 3, 2024 | Substantially Equivalent |
| K163511 | NovaGuard SA Pro Safety System | Feb 2, 2017 | Substantially Equivalent |
| K151777 | Intradermal Adapter | Sep 29, 2015 | Substantially Equivalent |
| K123588 | INTRADERMAL ADAPTER | Feb 19, 2013 | Substantially Equivalent |
| K082908 | NOVAGUARD, MODEL 3611001 | Apr 24, 2009 | Substantially Equivalent |