The following data is part of a premarket notification filed by Technical Products, Inc. with the FDA for Sil-tec Small/large Bore Tubing/sil-tec High Durometer Tubing/sil-tec Radiopaque Tubing.
| Device ID | K971613 |
| 510k Number | K971613 |
| Device Name: | SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING |
| Classification | Elastomer, Silicone Block |
| 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 | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1997-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B051XOP602285T0 | K971613 | 000 |
| B0516016850 | K971613 | 000 |
| B0516016450 | K971613 | 000 |
| B0516016250 | K971613 | 000 |
| B0516015650 | K971613 | 000 |
| B0516015450 | K971613 | 000 |
| B0516015250 | K971613 | 000 |
| B0516015050 | K971613 | 000 |
| B0516014950 | K971613 | 000 |
| B0516014850 | K971613 | 000 |
| B0516014650 | K971613 | 000 |
| B0516014450 | K971613 | 000 |
| B0516014250 | K971613 | 000 |
| B0516014050 | K971613 | 000 |
| B0516013650 | K971613 | 000 |
| B0516013350 | K971613 | 000 |
| B051601325H650 | K971613 | 000 |
| B051601325H600 | K971613 | 000 |
| B0516021000 | K971613 | 000 |
| B0516021050 | K971613 | 000 |
| B051602305H650 | K971613 | 000 |
| B051602305H600 | K971613 | 000 |
| B0516023050 | K971613 | 000 |
| B0516022850 | K971613 | 000 |
| B051602265T0 | K971613 | 000 |
| B051602265H650 | K971613 | 000 |
| B0516022650 | K971613 | 000 |
| B051602235H650 | K971613 | 000 |
| B051602235H600 | K971613 | 000 |
| B0516022350 | K971613 | 000 |
| B0516022150 | K971613 | 000 |
| B0516022050 | K971613 | 000 |
| B0516022000 | K971613 | 000 |
| B051602175T650 | K971613 | 000 |
| B0516021750 | K971613 | 000 |
| B0516021550 | K971613 | 000 |
| B0516021350 | K971613 | 000 |
| B0516013250 | K971613 | 000 |