FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GONAD SHIELD
K Number: K790639
·
Decision Apr 23, 1979
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
1
Review Days
24
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Basic Information
- Device Name
- GONAD SHIELD
- K Number
- K790639
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- The Mochlett Laboratories, Inc.
- Date Received
- March 30, 1979
- Decision Date
- April 23, 1979
- Product Code
- KPY
- 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 |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | FDA class 1 | Radiology |
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