The following data is part of a premarket notification filed by Chathamborough Research Group, Inc. with the FDA for Splatter Shield.
Device ID | K915676 |
510k Number | K915676 |
Device Name: | SPLATTER SHIELD |
Classification | Syringe, Piston |
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 | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-19 |
Decision Date | 1992-09-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPLATTER SHIELD 75031055 not registered Dead/Abandoned |
EZ Cover, Inc. 1995-12-11 |