510(k) K780646
K780646 is an FDA 510(k) premarket notification submitted by Medishield, Inc. for the device "AIR-PWOERED COLDRILL". The FDA issued a decision of Substantially Equivalent on April 28, 1978. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Medishield, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1978
- Date Received
- April 17, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type