510(k) K821127
K821127 is an FDA 510(k) premarket notification submitted by Key Medical, Inc. for the device "KEY DRILL". The FDA issued a decision of Substantially Equivalent on June 3, 1982. The device falls under product code GFG (Bit, Surgical), a Class I device regulated under 21 CFR 878.4820. Key Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1982
- Date Received
- April 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bit, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type