The following data is part of a premarket notification filed by Eastmed Inc. with the FDA for Uresta Pessary.
| Device ID | K081385 |
| 510k Number | K081385 |
| Device Name: | URESTA PESSARY |
| Classification | Pessary, Vaginal |
| Applicant | EASTMED INC. 4 INNOVATION DRIVE Dundas, CA L9h 7p3 |
| Contact | Shirley Furesz |
| Correspondent | Shirley Furesz EASTMED INC. 4 INNOVATION DRIVE Dundas, CA L9h 7p3 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-16 |
| Decision Date | 2008-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00692379000264 | K081385 | 000 |
| 10692379000247 | K081385 | 000 |
| 10692379000230 | K081385 | 000 |
| 10692379000223 | K081385 | 000 |
| 10692379000216 | K081385 | 000 |
| 10692379000209 | K081385 | 000 |