The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Sterile Mucous Specimen Trap, Disposable.
Device ID | K923098 |
510k Number | K923098 |
Device Name: | STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE |
Classification | Catheters, Suction, Tracheobronchial |
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 | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1992-09-21 |