The following data is part of a premarket notification filed by Medtronic Blood Management with the FDA for Modification Of Autotransfusion Apparatus (autolog).
Device ID | K982755 |
510k Number | K982755 |
Device Name: | MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) |
Classification | Apparatus, Autotransfusion |
Applicant | MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
Contact | Stephen Mckelvey |
Correspondent | Stephen Mckelvey MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-29 |
Decision Date | 1998-08-20 |
Summary: | summary |