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 |