510(k) K934970
K934970 is an FDA 510(k) premarket notification submitted by Trulife , Ltd. for the device "DUET". The FDA issued a decision of Substantially Equivalent on December 10, 1993. The device falls under product code GBJ (Prosthesis, Adhesive, External), a Class I device regulated under 21 CFR 878.3750.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1993
- Date Received
- October 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Adhesive, External
- Device Class
- Class I
- Regulation Number
- 878.3750
- Review Panel
- SU
- Submission Type