The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Maxima* Collapsible Venous Reservoir Bag & Holder.
Device ID | K873423 |
510k Number | K873423 |
Device Name: | MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
Contact | Denise A Carpenter |
Correspondent | Denise A Carpenter JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-25 |
Decision Date | 1987-11-06 |