510(k) K872209
K872209 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "ARTHROPLASTY MALLET". The FDA issued a decision of Substantially Equivalent on June 23, 1987. The device falls under product code HXL (Mallet), a Class I device regulated under 21 CFR 878.4800. New England Surgical Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1987
- Date Received
- June 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mallet
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type