FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
USA ASPIRATOR
K Number: K862751
·
Decision Aug 4, 1986
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
1
Review Days
13
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Basic Information
- Device Name
- USA ASPIRATOR
- K Number
- K862751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- U. S. A. Medical Corp.
- Date Received
- July 22, 1986
- Decision Date
- August 4, 1986
- Product Code
- BTA
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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