NIPLETTE— 510(k) K952035
Substantially EquivalentAvent America, Inc.
FDA 510(k) clearance K952035 for NIPLETTE, Substantially Equivalent on 1995-07-28. Applicant: Avent America, Inc.. Device class: 1.
Clearance details
- Applicant
- Avent America, Inc.
- Product code
- Code HGY
- Device class
- Class 1
- Regulation
- 21 CFR 884.5150
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Addison, IL, US
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