The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Irrigation Tray With Piston Syringe.
Device ID | K942221 |
510k Number | K942221 |
Device Name: | IRRIGATION TRAY WITH PISTON SYRINGE |
Classification | Syringe, Piston |
Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Contact | Parth Basumallik |
Correspondent | Parth Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-06 |
Decision Date | 1994-08-05 |