510(k) K960685
K960685 is an FDA 510(k) premarket notification submitted by Integrated Surgical Systems, Inc. for the device "ORTHODOC PREOPERATIVE PLANNER MODEL 500". The FDA issued a decision of Substantially Equivalent on January 17, 1997. The device falls under product code HWT (Template), a Class I device regulated under 21 CFR 888.4800. Integrated Surgical Systems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1997
- Date Received
- February 20, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Template
- Device Class
- Class I
- Regulation Number
- 888.4800
- Review Panel
- OR
- Submission Type