510(k) K853016
K853016 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "STILLE ANGULAR RONGEUR, 8-3/4 SS 410". The FDA issued a decision of Substantially Equivalent on August 7, 1985. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1985
- Date Received
- July 17, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No