LAPARETTE— 510(k) K971146
Substantially EquivalentRd Chus, Inc.
FDA 510(k) clearance K971146 for LAPARETTE, Substantially Equivalent on 1997-08-25. Applicant: Rd Chus, Inc.. Device class: 2.
Clearance details
- Applicant
- Rd Chus, Inc.
- Product code
- Code KNF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code KNF
view all- K250705 — Sonata Transcervical Fibroid Ablation System 2.2
- K240503 — Sonata Transcervical Fibroid Ablation System 2.2
- K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
- K222304 — Sonata Transcervical Fibroid Ablation System 2.2
- K211535 — Sonata Transcervical Fibroid Ablation System 2.2
Data sourced from openFDA. This site is unofficial and independent of the FDA.