The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Adult Perm-cath 40cm..
Device ID | K871749 |
510k Number | K871749 |
Device Name: | ADULT PERM-CATH 40CM. |
Classification | Catheter, Subclavian |
Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Contact | Randy Walls |
Correspondent | Randy Walls QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Product Code | LFJ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-05 |
Decision Date | 1987-06-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521009981 | K871749 | 000 |
20884521009834 | K871749 | 000 |
20884521795300 | K871749 | 000 |