NEURALMAS
FDA 510(k) clearance K100992 · decided 2010-09-24
Clearance details
- K-number
- K100992
- Device name
- NEURALMAS
- Applicant
- Innovative Surgical Solutions, LLC ("Iss")
- Decision
- Substantially Equivalent
- Date received
- 2010-04-09
- Decision date
- 2010-09-24
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.