PRIMEAIRE

Nebulizer (direct Patient Interface)

THAYER MEDICAL CORP.

The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Primeaire.

Pre-market Notification Details

• Device ID: K992722
• 510k Number: K992722
• Device Name: PRIMEAIRE
• Classification: Nebulizer (direct Patient Interface)
• Applicant: THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714
• Contact: David T Sladek
• Correspondent: David T Sladek; THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-13
• Decision Date: 1999-11-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00383480000051	K992722	000