The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for S3 Mast Pump.
Device ID | K972321 |
510k Number | K972321 |
Device Name: | S3 MAST PUMP |
Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
Applicant | STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Rosina Robinson |
Correspondent | Rosina Robinson STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | DWB |
CFR Regulation Number | 870.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-23 |
Decision Date | 1998-02-27 |
Summary: | summary |