SAFE-T-SHIELD MOUTHPIECE— 510(k) K865093

Name: FDA 510(k) clearance K865093
Creator: U.S. Food and Drug Administration
Published: 1987-01-15

Substantially Equivalent

Medi Nuclear Corp., Inc.

FDA 510(k) clearance K865093 for SAFE-T-SHIELD MOUTHPIECE, Substantially Equivalent on 1987-01-15. Applicant: Medi Nuclear Corp., Inc.. Device class: 1.

Clearance details

Applicant: Medi Nuclear Corp., Inc.
Product code: Code BYP
Device class: Class 1
Regulation: 21 CFR 868.5620
Advisory panel: Anesthesiology
Date received: 1986-12-30
Decision date: 1987-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin Park, CA, US

Download summary PDF View on FDA.gov ↗

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