The following data is part of a premarket notification filed by Avent America, Inc. with the FDA for Niplette.
Device ID | K952035 |
510k Number | K952035 |
Device Name: | NIPLETTE |
Classification | Pump, Breast, Non-powered |
Applicant | AVENT AMERICA, INC. 1765 W. CORTLAND COURT, UNIT L Addison, IL 60101 |
Contact | Elizabeth Iverson |
Correspondent | Elizabeth Iverson AVENT AMERICA, INC. 1765 W. CORTLAND COURT, UNIT L Addison, IL 60101 |
Product Code | HGY |
CFR Regulation Number | 884.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-01 |
Decision Date | 1995-07-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NIPLETTE 75057451 not registered Dead/Abandoned |
CANNON RUBBER LIMITED 1996-02-13 |
NIPLETTE 74410222 2059569 Live/Registered |
AVENT LIMITED 1993-07-06 |