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 |