The following data is part of a premarket notification filed by Deltec Systems, Inc. with the FDA for Cadd-pac 5200 Ambulatory Infusion Pump.
Device ID | K843773 |
510k Number | K843773 |
Device Name: | CADD-PAC 5200 AMBULATORY INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | DELTEC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Thomas A Dougherty |
Correspondent | Thomas A Dougherty DELTEC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-25 |
Decision Date | 1984-12-06 |