510(k) K851105
K851105 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/". The FDA issued a decision of Substantially Equivalent on May 15, 1985. The device falls under product code EMG (Forceps, Tooth Extractor, Surgical), a Class I device regulated under 21 CFR 872.4565. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1985
- Date Received
- March 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Tooth Extractor, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type