The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Clear Advantage Ii.
Device ID | K945628 |
510k Number | K945628 |
Device Name: | CLEAR ADVANTAGE II |
Classification | Device, Incontinence, Urosheath Type, Sterile |
Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
Contact | Byron H Wicket |
Correspondent | Byron H Wicket MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
Product Code | EXJ |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-16 |
Decision Date | 1995-07-06 |