Mariachi Oy

FDA Filings

This page includes the latest FDA filings for Mariachi Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010287677
• FEI Number: 3010287677
• Name: Gary Mocnik
• Owner & Operator: Mariachi Oy
• Contact Address: Kaarinantie 700 ; Turku FI-LS Lansi-Suomen laani 20540 FI
• Official Correspondent:
  • Pasi Hatakka
  • 358-20-7281640-x
• US Agent:
  • Gary Mocnik
  • Gary S. Mocnik and Associates
  • 949 4330413
  • gmocnik@cox.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 49 Coastal Oak ; Aliso Viejo, CA 92656 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K153694 | HKY Gary Mocnik [Mariachi Oy]	Icare Ic100	2016-12-23
PMN K153694 | HKX Gary Mocnik [Mariachi Oy]	Icare Ic100	2016-12-23
PMN K063873 | HKY Gary Mocnik [Mariachi Oy]	iCare; iCare tonometer	2013-01-24
PMN K063873 | HKX Gary Mocnik [Mariachi Oy]	iCare; iCare tonometer	2013-01-24