The following data is part of a premarket notification filed by Baxter Bentley Laboratories, Inc. with the FDA for Duraflo Ii Heparin Treated Suction Wands Var. Mod..
Device ID | K905311 |
510k Number | K905311 |
Device Name: | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. |
Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
Applicant | BAXTER BENTLEY LABORATORIES, INC. P.O. BOX 19522 Irvine, CA 92713 |
Contact | Donald A Raible |
Correspondent | Donald A Raible BAXTER BENTLEY LABORATORIES, INC. P.O. BOX 19522 Irvine, CA 92713 |
Product Code | DWD |
CFR Regulation Number | 870.4430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-28 |
Decision Date | 1991-01-15 |