DYNAREX TRACHEOSTOMY SPONGE— 510(k) K983348

Name: FDA 510(k) clearance K983348
Creator: U.S. Food and Drug Administration
Published: 1998-12-11

Substantially Equivalent

Dynarex Corp.

FDA 510(k) clearance K983348 for DYNAREX TRACHEOSTOMY SPONGE, Substantially Equivalent on 1998-12-11. Applicant: Dynarex Corp.. Device class: Unclassified.

Clearance details

Applicant: Dynarex Corp.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1998-09-23
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brewster, NY, US

Download summary PDF View on FDA.gov ↗

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