The following data is part of a premarket notification filed by Orelle Corporation Ltd with the FDA for Natratone.
Device ID | K121902 |
510k Number | K121902 |
Device Name: | NATRATONE |
Classification | Perineometer |
Applicant | ORELLE CORPORATION LTD 4739 - 44TH AVE S.W., UNIT 403 Seattle, WA 98116 |
Contact | Patricia Coombes |
Correspondent | Patricia Coombes ORELLE CORPORATION LTD 4739 - 44TH AVE S.W., UNIT 403 Seattle, WA 98116 |
Product Code | HIR |
CFR Regulation Number | 884.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-29 |
Decision Date | 2013-06-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() NATRATONE 77541536 3923586 Live/Registered |
ORELLE LTD 2008-08-07 |