The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Saline Wet Dressing- Sterile.
Device ID | K934258 |
510k Number | K934258 |
Device Name: | SALINE WET DRESSING- STERILE |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Contact | Partha Basumallik |
Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
Product Code | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-31 |
Decision Date | 1993-11-24 |