The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aries Meldical Model 2100hc Hank Crank.
| Device ID | K903925 |
| 510k Number | K903925 |
| Device Name: | ARIES MELDICAL MODEL 2100HC HANK CRANK |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | ARIES MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | James Mayol |
| Correspondent | James Mayol ARIES MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-13 |
| Decision Date | 1990-12-21 |