The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Lancaster Cooling Jacket, Cat. Code #13500/13501.
Device ID | K913077 |
510k Number | K913077 |
Device Name: | LANCASTER COOLING JACKET, CAT. CODE #13500/13501 |
Classification | Heat-exchanger, Cardiopulmonary Bypass |
Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Contact | Roger W Brink |
Correspondent | Roger W Brink DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Product Code | DTR |
CFR Regulation Number | 870.4240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-11 |
Decision Date | 1992-01-09 |