The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Curlcath.
Device ID | K872787 |
510k Number | K872787 |
Device Name: | MODIFIED CURLCATH |
Classification | Catheter, Continuous Irrigation |
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 | GBQ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-13 |
Decision Date | 1987-08-04 |