SPORTROL RAPID STERILITY INDICATOR— 510(k) K962649

Name: FDA 510(k) clearance K962649
Creator: U.S. Food and Drug Administration
Published: 1997-09-26

Substantially Equivalent

North American Science Assoc., Inc.

FDA 510(k) clearance K962649 for SPORTROL RAPID STERILITY INDICATOR, Substantially Equivalent on 1997-09-26. Applicant: North American Science Assoc., Inc.. Device class: 2.

Clearance details

Applicant: North American Science Assoc., Inc.
Product code: Code MTC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1996-07-08
Decision date: 1997-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northwood, OH, US

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