OPTI-MIST

Nebulizer (direct Patient Interface)

CORPAK CO.

The following data is part of a premarket notification filed by Corpak Co. with the FDA for Opti-mist.

Pre-market Notification Details

• Device ID: K820952
• 510k Number: K820952
• Device Name: OPTI-MIST
• Classification: Nebulizer (direct Patient Interface)
• Applicant: CORPAK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-04-06
• Decision Date: 1982-04-29