FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUNGSTEN SYRINGE SHIELD
K Number: K811688
·
Decision Jul 2, 1981
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
3
Applicant Total
9
Review Days
17
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Basic Information
- Device Name
- TUNGSTEN SYRINGE SHIELD
- K Number
- K811688
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Date Received
- June 15, 1981
- Decision Date
- July 2, 1981
- 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.
ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
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FDA Class 1
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LEAD GLASS SHIELDS
FDA 510(k)
FDA Class 1
·Radiology
DUFFY BOLUS INJECTOR
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging
| K Number | Device Name | ||
|---|---|---|---|
| K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 | Apr 11, 2001 | Substantially Equivalent |
| K940632 | I-125 RAPID STRAND | Sep 2, 1994 | Substantially Equivalent |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | Jul 1, 1992 | Substantially Equivalent |
| K915156 | I-125 SEEDS CODE: 6702 | Jan 6, 1992 | Substantially Equivalent |
| K914268 | I-125 SEEDS IN CARRIER, CODE: 6720 | Nov 22, 1991 | Substantially Equivalent |
| K914281 | I-125 SEEDS, CODE: 6711 | Nov 22, 1991 | Substantially Equivalent |
| K811677 | KRYPTON CART | Jul 2, 1981 | Substantially Equivalent |
| K811118 | KRYPTON MASKS & TUBING | Jun 2, 1981 | Substantially Equivalent |