The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Silagum.
Device ID | K792363 |
510k Number | K792363 |
Device Name: | SILAGUM |
Classification | Material, Impression |
Applicant | PARKELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-23 |
Decision Date | 1980-01-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SILAGUM 76176188 2787903 Dead/Cancelled |
ERNST MUHLBAUER GMBH & CO, KG 2000-12-05 |