FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTECTA COAT SPONGES
K Number: K840156
·
Decision Mar 23, 1984
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
28
Applicant Total
11
Review Days
70
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Basic Information
- Device Name
- PROTECTA COAT SPONGES
- K Number
- K840156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Alimed, Inc.
- Date Received
- January 13, 1984
- Decision Date
- March 23, 1984
- Product Code
- IZZ
- 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 |
|---|---|---|---|
| IZZ | Table, Radiographic, Non-Tilting, Powered | FDA class 2 | Radiology |
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|---|---|---|---|
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