The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for Willi Geller Creation & Av Porcelain.
Device ID | K002041 |
510k Number | K002041 |
Device Name: | WILLI GELLER CREATION & AV PORCELAIN |
Classification | Powder, Porcelain |
Applicant | JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
Contact | John Slanski |
Correspondent | John Slanski JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-05 |
Decision Date | 2000-08-16 |