FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GOLD SEADS
K Number: K834027
·
Decision Dec 27, 1983
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
2
Review Days
35
Basic Information
- Device Name
- GOLD SEADS
- K Number
- K834027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- RADIATION SAFETY & NUCLEAR PRODUCTS, INC.
- Date Received
- November 22, 1983
- Decision Date
- December 27, 1983
- Product Code
- IWG
- 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 |
|---|---|---|---|
| IWG | Seed, Isotope, Gold, Titanium, Platinum | FDA class 2 | Radiology |
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Other Clearances by RADIATION SAFETY & NUCLEAR PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K850382 | IRIDIUM SEEDS | Aug 15, 1985 | Substantially Equivalent |