FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095— 510(k) K983338

Name: FDA 510(k) clearance K983338
Creator: U.S. Food and Drug Administration
Published: 1999-04-20

Substantially Equivalent

Nucletron Corp.

FDA 510(k) clearance K983338 for FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095, Substantially Equivalent on 1999-04-20. Applicant: Nucletron Corp.. Device class: 2.

Clearance details

Applicant: Nucletron Corp.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 1998-09-23
Decision date: 1999-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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