510(k) Premarket Notification

• Device Classification Name: nebulizer (direct patient interface)
• 510(K) Number: K111570
• Model: 1024A, 1025A, 1543A
• Device Name: MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
• Applicant: THAYER MEDICAL CORPORATION; 4575 south palo verde road; suite 337; tucson, AZ 85714 1961
• Contact: erika s strickland
• Regulation Number: 868.5630
• Classification Product Code: CAF
• Date Received: 06/06/2011
• Decision Date: 09/29/2011
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Anesthesiology
• Review Advisory Committee: Anesthesiology
• statement: statement
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No