510(k) K782092
K782092 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "ARMBOARD CVER, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on January 10, 1979. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Anago, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1979
- Date Received
- December 14, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Manual
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type