The following data is part of a premarket notification filed by Hu-friedy Mfg. Co., Inc with the FDA for Ei Downpak Barrier Sleeves.
| Device ID | K073369 |
| 510k Number | K073369 |
| Device Name: | EI DOWNPAK BARRIER SLEEVES |
| Classification | Gutta-percha |
| Applicant | HU-FRIEDY MFG. CO., INC 3232 N. ROCKWELL STREET Chicago, IL 60618 |
| Contact | Keith Dunn |
| Correspondent | Keith Dunn HU-FRIEDY MFG. CO., INC 3232 N. ROCKWELL STREET Chicago, IL 60618 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-30 |
| Decision Date | 2008-02-27 |
| Summary: | summary |