510(k) K974654
- Device
- SILICONE BLOCKS
- Applicant
- Specialty Surgical Products, Inc.
- 510(k) number
- K974654
- Product code
- MIB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-24
- Date received
- 1997-12-15
- Regulation
- 874.3620
- Classification name
- Elastomer, Silicone Block
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- T. JAN VARNER
- Address
- 302 N. First St. Hamilton MT US 59840 59840
FDA Registration Numbers#
- 3010606546
- 1018470
- 2031444
- 3017496797
- 1061771
- 2939142
- 2182979
- 2029275
- 2028924
- 3003897287
- 3014664527
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MIB#
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|---|---|---|---|
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| K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | 2023-02-03 |
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| K200073 | AugMENTA Penile Implant | Augmenta, LLC | 2022-09-30 |
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022-05-13 |
| K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | 2020-07-20 |
| K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019-01-23 |
| K171851 | SOFTXIL | Bistool | 2018-03-16 |
| K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017-02-01 |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Implantech Associates, Inc. | 2005-11-04 |
| K052505 | CALF IMPLANT, MODEL EC17-X | Implantech Associates, Inc. | 2005-11-04 |
| K042054 | SILIMED PECTORAL IMPLANT | Silimed, Inc. | 2005-02-23 |
| K042380 | SILICONE BLOCK | National Medical Devices, Inc. | 2004-10-25 |
| K040042 | MEDISIL SILICONE SHEETING | Medisil Corporation | 2004-04-01 |
| K030808 | HANSON MEDICAL CALF IMPLANT | Hanson Medical, Inc. | 2003-04-21 |