The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Tri-med Paracentesis Tray.
Device ID | K932652 |
510k Number | K932652 |
Device Name: | TRI-MED PARACENTESIS TRAY |
Classification | General Surgery Tray |
Applicant | TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
Contact | Larry Scott |
Correspondent | Larry Scott TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-02 |
Decision Date | 1993-11-24 |