The following data is part of a premarket notification filed by Parker Hannifin Corp. with the FDA for Parker Ambulatory Medication Infusion Pump 2004.
Device ID | K897086 |
510k Number | K897086 |
Device Name: | PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 |
Classification | Pump, Infusion |
Applicant | PARKER HANNIFIN CORP. 17352 VON KARMAN AVE. Irvine, CA 92614 -6204 |
Contact | Steve A Wirtz |
Correspondent | Steve A Wirtz PARKER HANNIFIN CORP. 17352 VON KARMAN AVE. Irvine, CA 92614 -6204 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-20 |
Decision Date | 1990-09-28 |