The following data is part of a premarket notification filed by G & J Electronics, Inc. with the FDA for Distender Series Ii Barostat.
| Device ID | K991288 |
| 510k Number | K991288 |
| Device Name: | DISTENDER SERIES II BAROSTAT |
| 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 | 1999-04-14 |
| Decision Date | 1999-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627843670957 | K991288 | 000 |
| 00627843670940 | K991288 | 000 |
| 00627843670933 | K991288 | 000 |
| 00627843670926 | K991288 | 000 |
| 00627843670919 | K991288 | 000 |
| 00627843670902 | K991288 | 000 |
| 00627843670896 | K991288 | 000 |
| 00627843670889 | K991288 | 000 |
| 00627843670872 | K991288 | 000 |