The following data is part of a premarket notification filed by Intrinsic Therapeutics, Inc. with the FDA for Barricaid Instrument Tray.
Device ID | K201676 |
510k Number | K201676 |
Device Name: | Barricaid Instrument Tray |
Classification | Defect Measurement Tool |
Applicant | Intrinsic Therapeutics, Inc. 30 Commerce Way Woburn, MA 01801 |
Contact | Regina Shih |
Correspondent | Regina Shih Intrinsic Therapeutics, Inc. 30 Commerce Way Woburn, MA 01801 |
Product Code | QHG |
CFR Regulation Number | 888.4510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-19 |
Decision Date | 2020-07-16 |