The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Blood Tubing Set With Transducer Protector And Priming Set, Model A201-a219, V801-v806, 5m9634, 5m9693.
Device ID | K072024 |
510k Number | K072024 |
Device Name: | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 |
Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
Applicant | NIPRO MEDICAL CORP. 3150 NW 107 AVE.. Miami, FL 33172 |
Contact | Jessica Oswald |
Correspondent | Jessica Oswald NIPRO MEDICAL CORP. 3150 NW 107 AVE.. Miami, FL 33172 |
Product Code | FJK |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-24 |
Decision Date | 2007-10-04 |
Summary: | summary |