The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extracorporeal Maxima Hollow Fiber Oxygenator.
| Device ID | K843955 |
| 510k Number | K843955 |
| Device Name: | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Contact | James J Brennan |
| Correspondent | James J Brennan EXTRACORPOREAL MEDICAL SPECIALITIES, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-09 |
| Decision Date | 1984-11-29 |