The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Gastroplasty Calibrating Tube & Gastrostenometer.
| Device ID | K874690 |
| 510k Number | K874690 |
| Device Name: | GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Contact | Lynn R Breckenridge |
| Correspondent | Lynn R Breckenridge MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-16 |
| Decision Date | 1988-02-08 |