The following data is part of a premarket notification filed by Enhanced Perfusion Systems, Inc. with the FDA for Gentle Header.
| Device ID | K902845 |
| 510k Number | K902845 |
| Device Name: | GENTLE HEADER |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | ENHANCED PERFUSION SYSTEMS, INC. P.O. BOX 418 Grass Lake, MI 49240 |
| Contact | Walt Carpenter |
| Correspondent | Walt Carpenter ENHANCED PERFUSION SYSTEMS, INC. P.O. BOX 418 Grass Lake, MI 49240 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-28 |
| Decision Date | 1990-12-03 |