FITPACK

Container, Sharps

ASP PLASTICS PTY LTD.

The following data is part of a premarket notification filed by Asp Plastics Pty Ltd. with the FDA for Fitpack.

Pre-market Notification Details

• Device ID: K060037
• 510k Number: K060037
• Device Name: FITPACK
• Classification: Container, Sharps
• Applicant: ASP PLASTICS PTY LTD. 2700 LA PAZ ROAD, SUITE 314 Mission Viejo, CA 92691
• Contact: Albert Rego
• Correspondent: Albert Rego; ASP PLASTICS PTY LTD. 2700 LA PAZ ROAD, SUITE 314 Mission Viejo, CA 92691
• Product Code: MMK
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-06
• Decision Date: 2006-07-25