TYGON PAC-MONITORING LINES & FLUID ADMIN

Stopcock, I.v. Set

NORTON PERFORMANCE PLASTICS CORP.

The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Tygon Pac-monitoring Lines & Fluid Admin.

Pre-market Notification Details

• Device ID: K770707
• 510k Number: K770707
• Device Name: TYGON PAC-MONITORING LINES & FLUID ADMIN
• Classification: Stopcock, I.v. Set
• Applicant: NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FMG
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-04-18
• Decision Date: 1977-06-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B0663011780006	K770707	000
B0663011770006	K770707	000