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 |