The following data is part of a premarket notification filed by Norian Corp. with the FDA for Norian Cranial Repair System (crs)bone Cement- 5cc Kit, Norian Cranial Repair System (crs) Bone Cement- 10cc.
Device ID | K973789 |
510k Number | K973789 |
Device Name: | NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC |
Classification | Methyl Methacrylate For Cranioplasty |
Applicant | NORIAN CORP. 10260 BUBB RD. Cupertino, CA 95014 -4166 |
Contact | Susanne T Smith |
Correspondent | Susanne T Smith NORIAN CORP. 10260 BUBB RD. Cupertino, CA 95014 -4166 |
Product Code | GXP |
CFR Regulation Number | 882.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-06 |
Decision Date | 1998-05-18 |
Summary: | summary |