The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Y-type Blood Administration Set.
Device ID | K940074 |
510k Number | K940074 |
Device Name: | Y-TYPE BLOOD ADMINISTRATION SET |
Classification | Set, Blood Transfusion |
Applicant | PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
Contact | Thomas P Dimaio |
Correspondent | Thomas P Dimaio PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-06 |
Decision Date | 1994-04-21 |