The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Alloplastic Spermatocele.
Device ID | K863565 |
510k Number | K863565 |
Device Name: | MENTOR ALLOPLASTIC SPERMATOCELE |
Classification | Spermatocele, Alloplastic |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Byron Wickett |
Correspondent | Byron Wickett MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Product Code | LQS |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-12 |
Decision Date | 1986-11-19 |