510(k) K914830
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1991
- Date Received
- October 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator, Therapeutic
- Device Class
- Class I
- Regulation Number
- 890.5975
- Review Panel
- PM
- Submission Type