Cleared Traditional

TYGON M-60/TYGON M-70

K770299 · Norton Performance Plastics Corp. · Gastroenterology & Urology

Mar 1977

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K770299 is an FDA 510(k) clearance for the TYGON M-60/TYGON M-70, a Tubing, Dialysate (Class II — Special Controls, product code FID), submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1977, 30 days after receiving the submission on February 14, 1977. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K770299 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 1977
Decision Date	March 16, 1977
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—