The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Catheter, Sampling, Conduit.
Device ID | K771066 |
510k Number | K771066 |
Device Name: | CATHETER, SAMPLING, CONDUIT |
Classification | Catheter And Tube, Suprapubic |
Applicant | MENTOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FEZ |
CFR Regulation Number | 876.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-13 |
Decision Date | 1977-07-11 |