FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUKULYTE
K Number: K953610
·
Decision Sep 26, 1995
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
3
Review Days
55
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Basic Information
- Device Name
- AUKULYTE
- K Number
- K953610
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aukland Medical Plastics, Inc.
- Date Received
- August 2, 1995
- Decision Date
- September 26, 1995
- 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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