510(k) K822428
K822428 is an FDA 510(k) premarket notification submitted by Surgi-Quip Inc.U for the device "SURGI-QUIP MICROSCOPE STAND". The FDA issued a decision of Substantially Equivalent on September 2, 1982. The device falls under product code HBN (Chair, Neurosurgical), a Class I device regulated under 21 CFR 882.4125. Surgi-Quip Inc.U has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1982
- Date Received
- August 12, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Neurosurgical
- Device Class
- Class I
- Regulation Number
- 882.4125
- Review Panel
- NE
- Submission Type