The following data is part of a premarket notification filed by Entracare Corp. with the FDA for Ratesaver Plus.
Device ID | K952671 |
510k Number | K952671 |
Device Name: | RATESAVER PLUS |
Classification | Pump, Infusion, Enteral |
Applicant | ENTRACARE CORP. 15731 WEST 100TH TERRACE Lenexa, KS 66219 |
Contact | Al Boedeker |
Correspondent | Al Boedeker ENTRACARE CORP. 15731 WEST 100TH TERRACE Lenexa, KS 66219 |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-12 |
Decision Date | 1995-08-18 |