The following data is part of a premarket notification filed by Parker Hannifin Corp. with the FDA for Plasma Therapy Tubeset-e100 Series.
Device ID | K831747 |
510k Number | K831747 |
Device Name: | PLASMA THERAPY TUBESET-E100 SERIES |
Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
Applicant | PARKER HANNIFIN CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FJK |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-01 |
Decision Date | 1983-06-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10868465000112 | K831747 | 000 |
10868465000105 | K831747 | 000 |