The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Suture Used In Catheter Insertion Trays.
Device ID | K892450 |
510k Number | K892450 |
Device Name: | MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS |
Classification | Tape And Bandage, Adhesive |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Ron R Duck |
Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1989-10-11 |