510(k) K952035
K952035 is an FDA 510(k) premarket notification submitted by Avent America, Inc. for the device "NIPLETTE". The FDA issued a decision of Substantially Equivalent on Jul 28, 1995. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Avent America, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 1995
- Date Received
- May 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pump, Breast, Non-Powered
- Device Class
- Class I
- Regulation Number
- 884.5150
- Review Panel
- OB
- Submission Type
- 510(k) Exempt