The following data is part of a premarket notification filed by Bainbridge Laboratories, Inc. with the FDA for Pyloritrak.
Device ID | K912215 |
510k Number | K912215 |
Device Name: | PYLORITRAK |
Classification | Helicobacter Pylori |
Applicant | BAINBRIDGE LABORATORIES, INC. 7861 DAY RD. WEST Bainbridge Island, WA 98110 |
Contact | Max Lyon |
Correspondent | Max Lyon BAINBRIDGE LABORATORIES, INC. 7861 DAY RD. WEST Bainbridge Island, WA 98110 |
Product Code | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-20 |
Decision Date | 1991-10-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PYLORITRAK 74125962 1809874 Dead/Cancelled |
BAINBRIDGE SCIENCES, INC. 1990-12-24 |