510(k) K923776
K923776 is an FDA 510(k) premarket notification submitted by Neimark Labs, Inc. for the device "BENDEREV DRILL GUIDE". The FDA issued a decision of Substantially Equivalent on November 6, 1992. The device falls under product code HXY (Brace, Drill), a Class I device regulated under 21 CFR 888.4540. Neimark Labs, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1992
- Date Received
- July 28, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brace, Drill
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type