FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEND APC
K Number: K924094
·
Decision Mar 30, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
9
Applicant Total
3
Review Days
229
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Basic Information
- Device Name
- MEND APC
- K Number
- K924094
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mend Technologies, Inc.
- Date Received
- August 13, 1992
- Decision Date
- March 30, 1993
- Product Code
- JEA
- 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 |
|---|---|---|---|
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | FDA class 1 | General, Plastic Surgery |
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