510(k) K781887
K781887 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "9100 DAYSTAR AND 9110 ORBITER PACKAGE". The FDA issued a decision of Substantially Equivalent on December 12, 1978. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Castle Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1978
- Date Received
- November 7, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Ceiling Mounted
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type