510(k) K963704
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 1996
- Date Received
- September 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, Manual
- Device Class
- Class I
- Regulation Number
- 890.5660
- Review Panel
- PM
- Submission Type