The following data is part of a premarket notification filed by U.s. Biomaterials Corp. with the FDA for Perioglas - Bioglass Bone Graft Particulate.
| Device ID | K962494 |
| 510k Number | K962494 |
| Device Name: | PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | U.S. BIOMATERIALS CORP. ONE PROGRESS BLVD. BOX 23 Alachua, FL 32615 |
| Contact | Daphna R Ariel |
| Correspondent | Daphna R Ariel U.S. BIOMATERIALS CORP. ONE PROGRESS BLVD. BOX 23 Alachua, FL 32615 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-26 |
| Decision Date | 1996-09-20 |
| Summary: | summary |