510(k) K972367
K972367 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT". The FDA issued a decision of Substantially Equivalent on September 4, 1997. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Stryker Instruments has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1997
- Date Received
- June 25, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type