FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
K Number: K934549
·
Decision Feb 19, 1994
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
3
Applicant Total
40
Review Days
150
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Basic Information
- Device Name
- ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
- K Number
- K934549
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Victoreen, Inc.
- Date Received
- September 22, 1993
- Decision Date
- February 19, 1994
- Product Code
- IWR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IWR | Holder, Syringe, Lead | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWR), ordered by most recent decision date.
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TUNGSTEN SYRINGE SHIELD
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