MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)— 510(k) K883416

Name: FDA 510(k) clearance K883416
Creator: U.S. Food and Drug Administration
Published: 1988-10-12

Substantially Equivalent

Scott All-Sports, Inc.

FDA 510(k) clearance K883416 for MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD), Substantially Equivalent on 1988-10-12. Applicant: Scott All-Sports, Inc.. Device class: 2.

Clearance details

Applicant: Scott All-Sports, Inc.
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 1988-08-15
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Monroe, LA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.