The following data is part of a premarket notification filed by Deltec Systems, Inc. with the FDA for Ac Adapter Accessory, Product Code 600123a.
Device ID | K870768 |
510k Number | K870768 |
Device Name: | AC ADAPTER ACCESSORY, PRODUCT CODE 600123A |
Classification | Pump, Infusion |
Applicant | DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
Contact | James E Leslie |
Correspondent | James E Leslie DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-26 |
Decision Date | 1987-03-13 |