510(k) K844017
K844017 is an FDA 510(k) premarket notification submitted by Rabar, Inc. for the device "MICROTENS 7757 T.E.N.S. STIMULATOR". The FDA issued a decision of Substantially Equivalent on November 30, 1984. The device falls under product code GFJ (Mallet, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Rabar, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1984
- Date Received
- October 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mallet, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type