The following data is part of a premarket notification filed by Chathamborough Research Group, Inc. with the FDA for Parker Micropump Model 2100.
Device ID | K902309 |
510k Number | K902309 |
Device Name: | PARKER MICROPUMP MODEL 2100 |
Classification | Pump, Infusion |
Applicant | CHATHAMBOROUGH RESEARCH GROUP, INC. 105 WEST ST. P.O. BOX DRAWER 929 Pittsboro, NC 27312 |
Contact | Tim Hubbard |
Correspondent | Tim Hubbard CHATHAMBOROUGH RESEARCH GROUP, INC. 105 WEST ST. P.O. BOX DRAWER 929 Pittsboro, NC 27312 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-23 |
Decision Date | 1990-08-17 |