FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTUM 3080SP SURGICAL TABLE
K Number: K971390
·
Decision May 15, 1997
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
17
Applicant Total
204
Review Days
31
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Basic Information
- Device Name
- QUANTUM 3080SP SURGICAL TABLE
- K Number
- K971390
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- April 14, 1997
- Decision Date
- May 15, 1997
- Product Code
- GDC
- 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 |
|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | FDA class 1 | General, Plastic Surgery |
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