The following data is part of a premarket notification filed by Sorensen Research with the FDA for Trauma Drainage Set 72t-32ttc.
Device ID | K781551 |
510k Number | K781551 |
Device Name: | TRAUMA DRAINAGE SET 72T-32TTC |
Classification | Apparatus, Autotransfusion |
Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-09-12 |
Decision Date | 1978-10-26 |