FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALLEN MALLEABLE ANESTHESIA SCREEN
K Number: K873370
·
Decision Sep 11, 1987
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
60
Applicant Total
3
Review Days
21
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Basic Information
- Device Name
- ALLEN MALLEABLE ANESTHESIA SCREEN
- K Number
- K873370
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Edgewater Medical Equipment Systems
- Date Received
- August 21, 1987
- Decision Date
- September 11, 1987
- Product Code
- FWZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | FDA class 1 | General, Plastic Surgery |
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