HYCURE
FDA 510(k) clearance K955506 · decided 1996-01-17
Clearance details
- K-number
- K955506
- Device name
- HYCURE
- Applicant
- The Hymed Group Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-01
- Decision date
- 1996-01-17
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.