The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Sculpting Resin.
| Device ID | K030585 |
| 510k Number | K030585 |
| Device Name: | SCULPTING RESIN |
| Classification | Coating, Filling Material, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Stephen Smith |
| Correspondent | Stephen Smith BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-24 |
| Decision Date | 2003-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757G93160 | K030585 | 000 |
| 00810111542395 | K030585 | 000 |