The following data is part of a premarket notification filed by Eastmed Inc. with the FDA for Modification To Uresta Pessary.
| Device ID | K083769 |
| 510k Number | K083769 |
| Device Name: | MODIFICATION TO URESTA PESSARY |
| Classification | Pessary, Vaginal |
| Applicant | EASTMED INC. 4 INNOVATION DRIVE Dundas, Ontario, CA L9h 7p3 |
| Contact | Roshana Ahmed |
| Correspondent | Roshana Ahmed EASTMED INC. 4 INNOVATION DRIVE Dundas, Ontario, CA L9h 7p3 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-18 |
| Decision Date | 2009-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00692379000264 | K083769 | 000 |
| 10692379000247 | K083769 | 000 |
| 10692379000230 | K083769 | 000 |
| 10692379000223 | K083769 | 000 |
| 10692379000216 | K083769 | 000 |
| 10692379000209 | K083769 | 000 |