Sil-Tec Small/Large Bore Tubing/Sil-Tec High Durometer Tubing/Sil-Tec Radiopaque Tubing
FDA 510(k) K971613 · Technical Products, Inc.
510(k) numberK971613
Submission
- Device name
- Sil-Tec Small/Large Bore Tubing/Sil-Tec High Durometer Tubing/Sil-Tec Radiopaque Tubing
- Applicant
- Technical Products, Inc.
Decatur, GA, US - Received
- May 2, 1997
- Decision date
- May 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIB – Elastomer, Silicone Block
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013321 | Silicone Tracheal T-TubesBTR · Traditional | 06/04/2002SE |
| K973385 | Oval ShapesHXA · Traditional | 12/05/1997SE |
| K973166 | Dow Corning Silastic Elastomer Q7-4750MIB · Traditional | 11/21/1997SE |
| K971472 | Sil-Tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced…FTL · Traditional | 07/01/1997SE |
| K954116 | Silicone Malecot Catheter with Pezzer/Mushroom TipFEW · Traditional | 11/06/1995SE |
Questions and answers
When was Sil-Tec Small/Large Bore Tubing/Sil-Tec High Durometer Tubing/Sil-Tec Radiopaque Tubing cleared by the FDA?
Sil-Tec Small/Large Bore Tubing/Sil-Tec High Durometer Tubing/Sil-Tec Radiopaque Tubing (K971613) received a 510(k) decision of Substantially Equivalent on May 22, 1997, 20 days after the submission was received.
What is the product code of K971613?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.