The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Evacare Vaginal Pessaries.
Device ID | K993308 |
510k Number | K993308 |
Device Name: | MENTOR EVACARE VAGINAL PESSARIES |
Classification | Pessary, Vaginal |
Applicant | MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
Contact | Donna A Crawford |
Correspondent | Donna A Crawford MENTOR CORP. 201 MENTOR DR. Santa Barbara, CA 93111 |
Product Code | HHW |
CFR Regulation Number | 884.3575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-04 |
Decision Date | 1999-12-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08519520070049 | K993308 | 000 |
08519520070007 | K993308 | 000 |
08519520070001 | K993308 | 000 |