510(k) K950889
K950889 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "ADEL 5000". The FDA issued a decision of Substantially Equivalent on October 16, 1995. The device falls under product code HDD (Table, Obstetrical, Ac-Powered (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1995
- Date Received
- February 28, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Obstetrical, Ac-Powered (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4900
- Review Panel
- OB
- Submission Type