AIRWAYS

Airway, Oropharyngeal, Anesthesiology

SEVEN HARVEST INTL. IMPORT & EXPORT

The following data is part of a premarket notification filed by Seven Harvest Intl. Import & Export with the FDA for Airways.

Pre-market Notification Details

• Device ID: K820709
• 510k Number: K820709
• Device Name: AIRWAYS
• Classification: Airway, Oropharyngeal, Anesthesiology
• Applicant: SEVEN HARVEST INTL. IMPORT & EXPORT 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: CAE
• CFR Regulation Number: 868.5110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-03-18
• Decision Date: 1982-06-25