FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LMI CHOLANGIOGRAM TRAY
K Number: K873471
·
Decision Oct 23, 1987
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
1
Review Days
56
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Basic Information
- Device Name
- LMI CHOLANGIOGRAM TRAY
- K Number
- K873471
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Lazarus Medical Innovations, Inc.
- Date Received
- August 28, 1987
- Decision Date
- October 23, 1987
- Product Code
- GBZ
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
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