510(k) K870845
K870845 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "WARSAW ORTHOPEDIC POINTED REAMER". The FDA issued a decision of Substantially Equivalent on Mar 11, 1987. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 1987
- Date Received
- Mar 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reamer
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type