FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLANTECH MEDICAL GRADE SILICONE SHEETING
K Number: K944408
·
Decision Nov 9, 1994
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
44
Applicant Total
7
Review Days
62
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Basic Information
- Device Name
- IMPLANTECH MEDICAL GRADE SILICONE SHEETING
- K Number
- K944408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- King & Spalding
- Date Received
- September 8, 1994
- Decision Date
- November 9, 1994
- Product Code
- MIB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MIB), ordered by most recent decision date.
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BioSiCar Silicone Implant
FDA 510(k)
FDA Class 2
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Other Clearances by King & Spalding
| K Number | Device Name | ||
|---|---|---|---|
| K942422 | PANASONIC WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent |
| K942423 | NAIS WRIST BLOOD PRESSURE METER | Feb 15, 1995 | Substantially Equivalent |
| K945998 | CHIN IMPLANT STYLE I | Feb 7, 1995 | Substantially Equivalent |
| K942421 | IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT | Aug 8, 1994 | Substantially Equivalent |
| K942420 | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT | Aug 8, 1994 | Substantially Equivalent |
| K941972 | HEMO-O-LOK | Jun 29, 1994 | Substantially Equivalent |