FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICAL GRADE SILICONE BLOCK
K Number: K952732
·
Decision Aug 31, 1995
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
44
Applicant Total
3
Review Days
77
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Basic Information
- Device Name
- MEDICAL GRADE SILICONE BLOCK
- K Number
- K952732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioplexus Corp.
- Date Received
- June 15, 1995
- Decision Date
- August 31, 1995
- 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 |
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