The following data is part of a premarket notification filed by Sunstar Americas, Inc. with the FDA for Guidor Bioresorbable Matrix Barrier.
| Device ID | K132325 |
| 510k Number | K132325 |
| Device Name: | GUIDOR BIORESORBABLE MATRIX BARRIER |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | SUNSTAR AMERICAS, INC. 575 8TH AVE, STE 1212 New York, NY 10018 |
| Contact | Deborah L Grayeski |
| Correspondent | Deborah L Grayeski SUNSTAR AMERICAS, INC. 575 8TH AVE, STE 1212 New York, NY 10018 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-26 |
| Decision Date | 2013-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00070942000079 | K132325 | 000 |
| 00070942000062 | K132325 | 000 |
| 00070942000055 | K132325 | 000 |
| 00070942000048 | K132325 | 000 |
| 00070942000031 | K132325 | 000 |
| 00070942000017 | K132325 | 000 |