FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPLACEABLE BATTERY PERFECTEMP 2 CAUT
K Number: K812644
·
Decision Oct 26, 1981
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
4
Review Days
39
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Basic Information
- Device Name
- REPLACEABLE BATTERY PERFECTEMP 2 CAUT
- K Number
- K812644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Key Medical, Inc.
- Date Received
- September 17, 1981
- Decision Date
- October 26, 1981
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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