510(k) K901166
K901166 is an FDA 510(k) premarket notification submitted by Dalton Technology, Inc. for the device "DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER". The FDA issued a decision of Substantially Equivalent on June 13, 1990. The device falls under product code HXX (Screwdriver), a Class I device regulated under 21 CFR 888.4540. Dalton Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1990
- Date Received
- March 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screwdriver
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type