510(k) K935356
K935356 is an FDA 510(k) premarket notification submitted by Amsco American Sterilizer Co. for the device "CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code FWW (Table, Operating-Room, Pneumatic), a Class I device regulated under 21 CFR 878.4960.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1994
- Date Received
- November 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- SU
- Submission Type