FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROTECTIVE RADIOGRAFIC GLOVE
K Number: K920538
·
Decision May 29, 1992
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
4
Applicant Total
3
Review Days
114
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Basic Information
- Device Name
- PROTECTIVE RADIOGRAFIC GLOVE
- K Number
- K920538
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Burkhart Roentgen Intl., Inc.
- Date Received
- February 5, 1992
- Decision Date
- May 29, 1992
- Product Code
- IWP
- 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 |
|---|---|---|---|
| IWP | Radiographic Protective Glove | FDA class 1 | Radiology |
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