510(k) K791073
K791073 is an FDA 510(k) premarket notification submitted by Truth, Inc. for the device "WRENCH". The FDA issued a decision of Substantially Equivalent on June 20, 1979. The device falls under product code HXC (Wrench), a Class I device regulated under 21 CFR 888.4540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 1979
- Date Received
- June 12, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrench
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type