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.
Device ID | K873813 |
510k Number | K873813 |
Device Name: | SARNS WARMER, PART #164975 AND #164980 |
Classification | Controller, Temperature, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Joseph W O'donnell |
Correspondent | Joseph W O'donnell 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Product Code | DWC |
CFR Regulation Number | 870.4250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-18 |
Decision Date | 1987-11-06 |