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 |