The following data is part of a premarket notification filed by Rabar, Inc. with the FDA for Microtens 7757 T.e.n.s. Stimulator.
Device ID | K844017 |
510k Number | K844017 |
Device Name: | MICROTENS 7757 T.E.N.S. STIMULATOR |
Classification | Mallet, Surgical, General & Plastic Surgery |
Applicant | RABAR, INC. 111 ONETA RD. Rochester, NY 14617 |
Contact | Bernard Weinstein |
Correspondent | Bernard Weinstein RABAR, INC. 111 ONETA RD. Rochester, NY 14617 |
Product Code | GFJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-15 |
Decision Date | 1984-11-30 |