510(k) K862629
K862629 is an FDA 510(k) premarket notification submitted by Simpson/Basye, Inc. for the device "SURGICAL LASER ACCESSORIES (SLA) CASE". The FDA issued a decision of Substantially Equivalent on July 17, 1986. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Simpson/Basye, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1986
- Date Received
- July 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Instrument
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type