CRYOSIL SILICONE GEL SHEETING
FDA 510(k) clearance K964047 · decided 1997-03-19
Clearance details
- K-number
- K964047
- Device name
- CRYOSIL SILICONE GEL SHEETING
- Applicant
- Biodermis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-09
- Decision date
- 1997-03-19
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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.