SARNS WARMER, PART #164975 AND #164980

Controller, Temperature, Cardiopulmonary Bypass

3M HEALTH CARE, SARNS

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Warmer, Part #164975 And #164980.

Pre-market Notification Details

Device IDK873813
510k NumberK873813
Device Name:SARNS WARMER, PART #164975 AND #164980
ClassificationController, Temperature, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactJoseph W O'donnell
CorrespondentJoseph W O'donnell
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeDWC  
CFR Regulation Number870.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-18
Decision Date1987-11-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.