510(k) K883522
K883522 is an FDA 510(k) premarket notification submitted by Amerimed US Corp. for the device "AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT". The FDA issued a decision of Substantially Equivalent on September 30, 1988. The device falls under product code LBK (Neurosurgical Ultrasonic Instruments), a Class U device. Amerimed US Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1988
- Date Received
- August 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Ultrasonic Instruments
- Device Class
- Class U
- Regulation Number
- Review Panel
- NE
- Submission Type