The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified 7 Inch Continuous Infusion Sets.
Device ID | K884102 |
510k Number | K884102 |
Device Name: | MODIFIED 7 INCH CONTINUOUS INFUSION SETS |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-09 |
Decision Date | 1989-01-31 |