Spectrum Designs Pre-Form Contour Silicone Carving Block
FDA 510(k) K982688 · Spectrum Designs, Inc.
510(k) numberK982688
Submission
- Device name
- Spectrum Designs Pre-Form Contour Silicone Carving Block
- Applicant
- Spectrum Designs, Inc.
Carpineteria, CA, US - Received
- August 3, 1998
- Decision date
- October 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K992522 | Spectrum Designs SpectragelMDA · Traditional | 10/26/1999SE |
| K980463 | Spectrum Designs Curvilinear Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980462 | Spectrum Designs Anatomical Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980446 | Spectrum Designs Anterior Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980445 | Spectrum Designs Concave Back Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980444 | Spectrum Designs Bilateral Groove Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980138 | Spectrum Designs Symmetrical Chin ImplantFWP · Traditional | 04/03/1998SE |
| K980461 | Spectrum Designs Cleft Chin ImplantFWP · Traditional | 03/04/1998SE |
| K980141 | Spectrum Designs Projection Malar ImplantLZK · Traditional | 03/03/1998SE |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | 03/03/1998SE |
Questions and answers
When was Spectrum Designs Pre-Form Contour Silicone Carving Block cleared by the FDA?
Spectrum Designs Pre-Form Contour Silicone Carving Block (K982688) received a 510(k) decision of Substantially Equivalent on October 13, 1998, 71 days after the submission was received.
What is the product code of K982688?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.