The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Seal Block Pro (not Finalized), Seal Block Otc (not Finalized).
| Device ID | K123653 |
| 510k Number | K123653 |
| Device Name: | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) |
| Classification | Varnish, Cavity |
| 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 | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-27 |
| Decision Date | 2013-06-03 |
| Summary: | summary |