The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Corporal Dilators.
Device ID | K860517 |
510k Number | K860517 |
Device Name: | MENTOR CORPORAL DILATORS |
Classification | Prosthesis, Penile |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Karen Edwards |
Correspondent | Karen Edwards MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Product Code | FAE |
CFR Regulation Number | 876.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-11 |
Decision Date | 1986-03-11 |