510(k) K781581
K781581 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "SURGICAL LIGHT 22 SERIES". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code FQP (Lamp, Operating-Room), a Class II device regulated under 21 CFR 878.4580. American Sterilizer Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1978
- Date Received
- September 15, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Operating-Room
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type