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 |