The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spaceoar System.
Device ID | K202224 |
510k Number | K202224 |
Device Name: | SpaceOAR System |
Classification | Hydrogel Spacer |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
Contact | Jeanne Otoole |
Correspondent | Jeanne Otoole Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
Product Code | OVB |
CFR Regulation Number | 892.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-07 |
Decision Date | 2020-08-28 |