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 |