FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE UNIVERSAL CEMENT PLUG(TM)
K Number: K910135
·
Decision Mar 5, 1991
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
5
Review Days
55
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Basic Information
- Device Name
- THE UNIVERSAL CEMENT PLUG(TM)
- K Number
- K910135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Biotron , Ltd.
- Date Received
- January 9, 1991
- Decision Date
- March 5, 1991
- Product Code
- LZN
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LZN | Cement Obturator | FDA class 2 | General, Plastic Surgery |
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