ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501— 510(k) K991526

Name: FDA 510(k) clearance K991526
Creator: U.S. Food and Drug Administration
Published: 1999-06-17

Substantially Equivalent

Imagyn Medical Technologies, Inc.

FDA 510(k) clearance K991526 for ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501, Substantially Equivalent on 1999-06-17. Applicant: Imagyn Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Imagyn Medical Technologies, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1999-05-03
Decision date: 1999-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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