FDA 510(k) Applications for Medical Device Product Code "MIB"
(Elastomer, Silicone Block)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K022511 | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. | AART CALF IMPLANT | 08/26/2002 |
| K021839 | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. | AART GLUTEAL IMPLANT | 07/16/2002 |
| K021820 | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. | AART SILICONE CARVING BLOCK | 07/16/2002 |
| K022223 | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. | AART SILICONE SHEETING | 08/08/2002 |
| K955368 | ALLIED BIOMEDICAL CORP. | DURALASTIC I | 02/08/1996 |
| K971480 | ALLIED BIOMEDICAL CORP. | DURALASTIC I AND DURALASTIC II | 05/28/1997 |
| K955370 | ALLIED BIOMEDICAL CORP. | DURALASTIC II | 02/08/1996 |
| K200073 | Augmenta LLC | AugMENTA Penile Implant | 09/30/2022 |
| K171851 | BISTOOL | SOFTXIL | 03/16/2018 |
| K973730 | HANSON MEDICAL, INC. | DURASIL I AND DURASIL II | 12/24/1997 |
| K030808 | HANSON MEDICAL, INC. | HANSON MEDICAL CALF IMPLANT | 04/21/2003 |
| K030809 | HANSON MEDICAL, INC. | HANSON MEDICAL GLUTEAL IMPLANT | 04/21/2003 |
| K973728 | HANSON MEDICAL, INC. | SILICONE CARVING BLOCK | 11/13/1997 |
| K052505 | IMPLANTECH ASSOCIATES INC. | CALF IMPLANT, MODEL EC17-X | 11/04/2005 |
| K052504 | IMPLANTECH ASSOCIATES INC. | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | 11/04/2005 |
| K162624 | INTERNATIONAL MEDICAL DEVICES, INC. | Pre-Formed Penile Silicone Block | 02/01/2017 |
| K181387 | International Medical Devices, Inc. | Pre-Formed Penile Silicone Block | 01/23/2019 |
| K220760 | International Medical Devices, Inc. | Pre-Formed Penile Silicone Block | 05/13/2022 |
| K223051 | International Medical Devices, Inc. | Pre-Formed Silicone Block | 02/03/2023 |
| K040042 | MEDISIL CORPORATION | MEDISIL SILICONE SHEETING | 04/01/2004 |
| K193392 | Metalware Technology Corp. | BioSiCar Silicone Implant | 07/20/2020 |
| K042380 | NATIONAL MEDICAL DEVICES, INC. | SILICONE BLOCK | 10/25/2004 |
| K961057 | RAND SCIENTIFIC CORP. | DURALASTIC SHEETING II | 05/16/1996 |
| K961081 | RAND SCIENTIFIC CORP. | SPIRIT RIDGE SILICONE CARVING BLOCK | 05/22/1996 |
| K983630 | SEARE BIOMEDICAL CORP. | SEARE BIOMEDICAL SILICONE RODS | 12/11/1998 |
| K983041 | SEARE BIOMEDICAL CORP. | SEARE BIOMEDICAL SILICONE SHEETING | 09/30/1998 |
| K222748 | Shineo Technology Co., Ltd | ShiNeo Silicone Implant | 12/23/2022 |
| K042054 | SILIMED, INC. | SILIMED PECTORAL IMPLANT | 02/23/2005 |
| K974480 | SILIMED, LLC. | SILIMED CALF IMPLANT | 02/24/1998 |
| K974482 | SILIMED, LLC. | SILIMED GLUTEAL IMPLANT | 02/24/1998 |
| K981851 | SILIMED, LLC. | SILIMED SILICONE CARVING BLOCK | 07/09/1998 |
| K974654 | SPECIALTY SURGICAL PRODUCTS, INC. | SILICONE BLOCKS | 02/24/1998 |
| K974653 | SPECIALTY SURGICAL PRODUCTS, INC. | SILICONE ELASTOMER SHEETING | 03/13/1998 |
| K982065 | SPECIALTY SURGICAL PRODUCTS, INC. | STERILE SILICONE EXTERNAL WOUND COVER | 08/12/1998 |
| K982688 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | 10/13/1998 |
| K960038 | SPECTRUM DESIGNS, INC. | SPECTRUM DESIGNS SILICONE BLOCK | 03/13/1996 |
| K973166 | TECHNICAL PRODUCTS, INC. | DOW CORNING SILASTIC ELASTOMER Q7-4750 | 11/21/1997 |
| K971613 | TECHNICAL PRODUCTS, INC. | SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING | 05/22/1997 |
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