510(k) K862933
K862933 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "ABC-1000 SMALL JOINT REAMERS". The FDA issued a decision of Substantially Equivalent on August 18, 1986. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1986
- Date Received
- August 4, 1986
- 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