The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Adapter-straight.
Device ID | K790564 |
510k Number | K790564 |
Device Name: | ADAPTER-STRAIGHT |
Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Applicant | DLP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTL |
CFR Regulation Number | 870.4290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-19 |
Decision Date | 1979-04-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00681490254892 | K790564 | 000 |
20613994918554 | K790564 | 000 |
20613994918547 | K790564 | 000 |
20613994756750 | K790564 | 000 |
20613994756729 | K790564 | 000 |
20613994756705 | K790564 | 000 |
20613994736745 | K790564 | 000 |
20613994736721 | K790564 | 000 |