The following data is part of a premarket notification filed by Degussa Corp. with the FDA for Deguprint.
Device ID | K955465 |
510k Number | K955465 |
Device Name: | DEGUPRINT |
Classification | Material, Impression |
Applicant | DEGUSSA CORP. 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Contact | Holger Meinicke |
Correspondent | Holger Meinicke DEGUSSA CORP. 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-30 |
Decision Date | 1995-12-28 |