The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extracorp.'s Intersept Cus. Tubing Pk..
Device ID | K800178 |
510k Number | K800178 |
Device Name: | EXTRACORP.'S INTERSEPT CUS. TUBING PK. |
Classification | Tubing, Pump, Cardiopulmonary Bypass |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DWE |
CFR Regulation Number | 870.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-28 |
Decision Date | 1980-02-21 |