510(k) K810303
K810303 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "TELEVISION CAMERA HOLDER FOR SURGERY". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code FXR (Holder, Camera, Surgical), a Class I device regulated under 21 CFR 878.4160. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1981
- Date Received
- February 5, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Camera, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type