The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Adapter-y Type/coronary Perfusion.
Device ID | K791498 |
510k Number | K791498 |
Device Name: | ADAPTER-Y TYPE/CORONARY PERFUSION |
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 | 1979-08-02 |
Decision Date | 1979-08-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169767683 | K791498 | 000 |
20613994685937 | K791498 | 000 |
20613994619710 | K791498 | 000 |
20613994619697 | K791498 | 000 |
20613994619673 | K791498 | 000 |
20613994619666 | K791498 | 000 |
20613994619659 | K791498 | 000 |
20613994619604 | K791498 | 000 |
20613994619598 | K791498 | 000 |
20613994619574 | K791498 | 000 |
20613994619567 | K791498 | 000 |
20613994685944 | K791498 | 000 |
20613994685951 | K791498 | 000 |
00681490860659 | K791498 | 000 |
00673978861388 | K791498 | 000 |
20643169018154 | K791498 | 000 |
20613994686064 | K791498 | 000 |
20613994686057 | K791498 | 000 |
20613994686040 | K791498 | 000 |
20613994685999 | K791498 | 000 |
20613994685982 | K791498 | 000 |
20613994685975 | K791498 | 000 |
20613994685968 | K791498 | 000 |
20613994619550 | K791498 | 000 |