FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGI-QUIP MICROSCOPE STAND
K Number: K822428
·
Decision Sep 2, 1982
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
8
Review Days
21
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Basic Information
- Device Name
- SURGI-QUIP MICROSCOPE STAND
- K Number
- K822428
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4125
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Surgi-Quip Inc.U
- Date Received
- August 12, 1982
- Decision Date
- September 2, 1982
- Product Code
- HBN
- Advisory Committee
- Neurology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| HBN | Chair, Neurosurgical | FDA class 1 | Neurology |
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Other Clearances by Surgi-Quip Inc.U
| K Number | Device Name | ||
|---|---|---|---|
| K841115 | CHARLES/MCINTYRE GIANT BREAK TABLE | May 9, 1984 | Substantially Equivalent |
| K841116 | MOBILE OPHTHALMIC OPERATING TABLE | May 9, 1984 | Substantially Equivalent |
| K840004 | WEE BAG O'MERCURY | Mar 22, 1984 | Substantially Equivalent |
| K832887 | ELECTRONIC UNIT | Oct 4, 1983 | Substantially Equivalent |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Sep 14, 1982 | Substantially Equivalent |
| K822554 | CEMENT EXTRACTION INSTRUMENTATION | Sep 14, 1982 | Substantially Equivalent |
| K822426 | MCINTYRE MICROSCOPE STAND | Sep 2, 1982 | Substantially Equivalent |