The following data is part of a premarket notification filed by Sorensen Research with the FDA for Receptal Ats Trauma Kga1900l.
Device ID | K772196 |
510k Number | K772196 |
Device Name: | RECEPTAL ATS TRAUMA KGA1900L |
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 | 1977-11-28 |
Decision Date | 1977-12-22 |