PK Lap Loop— 510(k) K142525
Substantially EquivalentOlympus Winter & Ibe GmbH
FDA 510(k) clearance K142525 for PK Lap Loop, Substantially Equivalent on 2014-11-21. Applicant: Olympus Winter & Ibe GmbH. Device class: 2.
Clearance details
- Applicant
- Olympus Winter & Ibe GmbH
- Product code
- Code HIN
- Device class
- Class 2
- Regulation
- 21 CFR 884.4150
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.