510(k) K781179
K781179 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "WRENCH, GEXAGON, DRIVER". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code DTF (Tools, Pacemaker Service), a Class I device regulated under 21 CFR 870.3730. Telectronics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1978
- Date Received
- July 14, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tools, Pacemaker Service
- Device Class
- Class I
- Regulation Number
- 870.3730
- Review Panel
- CV
- Submission Type