The following data is part of a premarket notification filed by U.s. Biomaterials Corp. with the FDA for Perioglass.
Device ID | K930115 |
510k Number | K930115 |
Device Name: | PERIOGLASS |
Classification | Bone Grafting Material, Synthetic |
Applicant | U.S. BIOMATERIALS CORP. ONE PROGRESS BLVD. Alachua, FL 32615 |
Contact | David C Greenspan |
Correspondent | David C Greenspan U.S. BIOMATERIALS CORP. ONE PROGRESS BLVD. 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 | 1993-01-11 |
Decision Date | 1993-11-04 |