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 |