The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Flat-span.
Device ID | K862049 |
510k Number | K862049 |
Device Name: | MENTOR FLAT-SPAN |
Classification | Expander, Skin, Inflatable |
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 | LCJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-29 |
Decision Date | 1986-06-10 |