FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAHE INSTRUMENTS
K Number: K942823
·
Decision Dec 5, 1994
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
3
Applicant Total
3
Review Days
174
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Basic Information
- Device Name
- MAHE INSTRUMENTS
- K Number
- K942823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mahe Intl., Inc.
- Date Received
- June 14, 1994
- Decision Date
- December 5, 1994
- Product Code
- DWG
- 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 |
|---|---|---|---|
| DWG | Electrosurgical Device | FDA class 2 | General, Plastic Surgery |
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