The following data is part of a premarket notification filed by Mooncup Limited with the FDA for Mooncup.
Device ID | K060852 |
510k Number | K060852 |
Device Name: | MOONCUP |
Classification | Cup, Menstrual |
Applicant | MOONCUP LIMITED DOLPHIN HOUSE 40 ARUNDEL STREET Brighton, GB Bn2 1gd |
Contact | Su Hardy |
Correspondent | Su Hardy MOONCUP LIMITED DOLPHIN HOUSE 40 ARUNDEL STREET Brighton, GB Bn2 1gd |
Product Code | HHE |
CFR Regulation Number | 884.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-28 |
Decision Date | 2006-12-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060053029996 | K060852 | 000 |
05060053028883 | K060852 | 000 |
05060053021129 | K060852 | 000 |
05060053022232 | K060852 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MOONCUP 98617101 not registered Live/Pending |
&Sisters Ltd 2024-06-25 |