EQUASHIELD SYSTEM PROTECTIVE PLUS
FDA 510(k) clearance K101940 · decided 2010-11-19
Clearance details
- K-number
- K101940
- Device name
- EQUASHIELD SYSTEM PROTECTIVE PLUS
- Applicant
- Equashield Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-12
- Decision date
- 2010-11-19
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Migdal, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.