The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Motility System.
Device ID | K862929 |
510k Number | K862929 |
Device Name: | SYNECTICS MOTILITY SYSTEM |
Classification | Electrode, Ph, Stomach |
Applicant | SYNECTICS-DANTEC 3710 WEST PIERCE ST. Milwaukee, WI 53215 |
Contact | Tord Lendau |
Correspondent | Tord Lendau SYNECTICS-DANTEC 3710 WEST PIERCE ST. Milwaukee, WI 53215 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-23 |
Decision Date | 1986-10-20 |