The following data is part of a premarket notification filed by Technical Products, Inc. with the FDA for Silicone Tracheal T-tubes.
| Device ID | K013321 |
| 510k Number | K013321 |
| Device Name: | SILICONE TRACHEAL T-TUBES |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Contact | Norbert D Thompson |
| Correspondent | Norbert D Thompson TECHNICAL PRODUCTS, INC. 2416 PARK CENTRAL BLVD. Decatur, GA 30035 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-05 |
| Decision Date | 2002-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| BO51TP140 | K013321 | 000 |
| B051TP08T1 | K013321 | 000 |
| B051TP09LT0 | K013321 | 000 |
| B051TP09T1 | K013321 | 000 |
| B051TP100 | K013321 | 000 |
| B051TP10LT0 | K013321 | 000 |
| B051TP110 | K013321 | 000 |
| B051TP11LT0 | K013321 | 000 |
| B051TP120 | K013321 | 000 |
| B051TP12LT0 | K013321 | 000 |
| B051TP13LT0 | K013321 | 000 |
| B051TP13T1 | K013321 | 000 |
| B051TP14LT0 | K013321 | 000 |
| B051TP160 | K013321 | 000 |
| B051TP16LT0 | K013321 | 000 |
| B051TP08LT0 | K013321 | 000 |