FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSIL MEDICAL GRADE SILICONE SHEETING
K Number: K932176
·
Decision Dec 2, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
32
Applicant Total
3
Review Days
211
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Basic Information
- Device Name
- BIOSIL MEDICAL GRADE SILICONE SHEETING
- K Number
- K932176
- 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
- May 5, 1993
- Decision Date
- December 2, 1993
- Product Code
- KHJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | FDA class 2 | Ear, Nose, Throat |
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