REMOTE CONTROL RADIOISOTOPE APPLICATOR— 510(k) K943109

Name: FDA 510(k) clearance K943109
Creator: U.S. Food and Drug Administration
Published: 1995-02-09

Substantially Equivalent

Inter-Pal GmbH

FDA 510(k) clearance K943109 for REMOTE CONTROL RADIOISOTOPE APPLICATOR, Substantially Equivalent on 1995-02-09. Applicant: Inter-Pal GmbH. Device class: 2.

Clearance details

Applicant: Inter-Pal GmbH
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 1994-06-29
Decision date: 1995-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palos Verdes Estates, CA, US

Download summary PDF View on FDA.gov ↗

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