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 |