INSTACINE
FDA 510(k) clearance K942558 · decided 1995-05-30
Clearance details
- K-number
- K942558
- Device name
- INSTACINE
- Applicant
- Fidelity Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-05-31
- Decision date
- 1995-05-30
- Days to decision
- 364 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Florham Park, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.