POLY-OP (TM)
FDA 510(k) clearance K900759 · decided 1990-05-24
Clearance details
- K-number
- K900759
- Device name
- POLY-OP (TM)
- Applicant
- Nu-Gyn-Tek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-16
- Decision date
- 1990-05-24
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- OCF
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oakfield, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.