The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Custom Tubing Sets.
Device ID | K790604 |
510k Number | K790604 |
Device Name: | CUSTOM TUBING SETS |
Classification | Set, Administration, Intravascular |
Applicant | NORTON PERFORMANCE PLASTICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-19 |
Decision Date | 1979-05-04 |