The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Modified Gelman Arterial Filter.
| Device ID | K892387 |
| 510k Number | K892387 |
| Device Name: | MODIFIED GELMAN ARTERIAL FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Contact | Arthur Pelletier |
| Correspondent | Arthur Pelletier GELMAN SCIENCES, INC. 600 SOUTH WAGNER RD. Ann Arbor, MI 48103 -9019 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-14 |
| Decision Date | 1989-06-22 |