BIOSIL MEDICAL GRADE SILICONE SHEETING
FDA 510(k) clearance K932176 · decided 1993-12-02
Clearance details
- K-number
- K932176
- Device name
- BIOSIL MEDICAL GRADE SILICONE SHEETING
- Applicant
- Bioplexus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-05
- Decision date
- 1993-12-02
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- KHJ
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Las Vegas, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.