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 |