510(k) K902359
K902359 is an FDA 510(k) premarket notification submitted by Seitz Technical Products, Inc. for the device "SURGICAL VIDEO CAMERA, MODEL 9500". The FDA issued a decision of Substantially Equivalent on July 12, 1990. The device falls under product code FWB (Camera, Television, Surgical, Without Audio), a Class I device regulated under 21 CFR 878.4160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1990
- Date Received
- May 29, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Surgical, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type