510(k) K770861
K770861 is an FDA 510(k) premarket notification submitted by Affiliated Hospital Products, Inc. for the device "SURGICAL COLDLIGHT, AX8". The FDA issued a decision of Substantially Equivalent on June 17, 1977. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Affiliated Hospital Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1977
- Date Received
- May 9, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type