510(k) K833509
K833509 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "CHEMONUCLEOLYSIS TABLE". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code FWY (Table, Operating-Room, Non-Electrical), a Class I device regulated under 21 CFR 878.4950. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1983
- Date Received
- October 11, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Non-Electrical
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type