SAFEPASS STERILIZATION POUCH— 510(k) K973981

Name: FDA 510(k) clearance K973981
Creator: U.S. Food and Drug Administration
Published: 1998-01-29

Substantially Equivalent

Adroit Medical Systems, Inc.

FDA 510(k) clearance K973981 for SAFEPASS STERILIZATION POUCH, Substantially Equivalent on 1998-01-29. Applicant: Adroit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Adroit Medical Systems, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1997-10-20
Decision date: 1998-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Loudon, TN, US

Download summary PDF View on FDA.gov ↗

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