FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
K Number: K981922
·
Decision Dec 10, 1998
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
4
Review Days
192
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Basic Information
- Device Name
- LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
- K Number
- K981922
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microaire Surgical Instruments, Inc.
- Date Received
- June 1, 1998
- Decision Date
- December 10, 1998
- Product Code
- QPB
- 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 |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
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