The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for The Lf-p Ceramic System.
Device ID | K050838 |
510k Number | K050838 |
Device Name: | THE LF-P CERAMIC SYSTEM |
Classification | Powder, Porcelain |
Applicant | JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
Contact | Gary Phelps |
Correspondent | Gary Phelps JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-01 |
Decision Date | 2005-05-04 |
Summary: | summary |