510(k) K780730
K780730 is an FDA 510(k) premarket notification submitted by Jay-Mar INternational Enterprises, IN for the device "FIGURETRIM". The FDA issued a decision of Substantially Equivalent on May 9, 1978. The device falls under product code ISB (Stimulator, Muscle, Diagnostic), a Class II device regulated under 21 CFR 890.1850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1978
- Date Received
- May 2, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Diagnostic
- Device Class
- Class II
- Regulation Number
- 890.1850
- Review Panel
- PM
- Submission Type