The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Tri-med Quick-step(tm) Rectal Tube.
| Device ID | K924549 |
| 510k Number | K924549 |
| Device Name: | TRI-MED QUICK-STEP(TM) RECTAL TUBE |
| Classification | Catheter, Rectal |
| 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 | GBT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-09 |
| Decision Date | 1994-02-10 |