The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Pro-v Coat.
Device ID | K103514 |
510k Number | K103514 |
Device Name: | PRO-V COAT |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Contact | Michelle Schiltz-taing |
Correspondent | Michelle Schiltz-taing BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-30 |
Decision Date | 2011-05-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D757H4011P1 | K103514 | 000 |
D757H40110 | K103514 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRO-V COAT 77314622 3702250 Live/Registered |
Bisco, Inc. 2007-10-26 |