The following data is part of a premarket notification filed by Taiji Medical Supplies, Inc. with the FDA for Taiji Professional Series Level 3 Surgical Face Mask.
Device ID | K211861 |
510k Number | K211861 |
Device Name: | TAIJI Professional Series Level 3 Surgical Face Mask |
Classification | Mask, Surgical |
Applicant | Taiji Medical Supplies, Inc. 3211 Progress Drive Lincolnton, NC 28092 |
Contact | Katherine Giannamore |
Correspondent | Abdel B Halim Global Quality And Regulatory Services 10 Scenic Way Monroe, NJ 08831 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2021-06-16 |
Decision Date | 2021-07-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10860007355902 | K211861 | 000 |