The following data is part of a premarket notification filed by G & J Electronics, Inc. with the FDA for Gastric And Rectal Catheters.
Device ID | K973844 |
510k Number | K973844 |
Device Name: | GASTRIC AND RECTAL CATHETERS |
Classification | System, Gastrointestinal Motility (electrical) |
Applicant | G & J ELECTRONICS, INC. 6 DORNFELL ST. Toronto, Ontario, CA M2r 2y6 |
Contact | Sam Jundler |
Correspondent | Sam Jundler G & J ELECTRONICS, INC. 6 DORNFELL ST. Toronto, Ontario, CA M2r 2y6 |
Product Code | FFX |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-08 |
Decision Date | 1999-06-04 |