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FDA 510(k), K900759, POLY-OP (TM)
FDA 510(k), K900759, POLY-OP (TM)
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510(K) Number: K900759
Device Name: POLY-OP (TM)
Manufacturer: NU-GYN-TEK, INC.
Device Classification Name: stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief
Regulation Number: 882.5890
Classification Product Code: OCF
Date Received: 02/16/1990
Decision Date: 05/24/1990
Regulation Medical Specialty: Neurology
Device Name: POLY-OP (TM)
Manufacturer: NU-GYN-TEK, INC.
Device Classification Name: stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief
Regulation Number: 882.5890
Classification Product Code: OCF
Date Received: 02/16/1990
Decision Date: 05/24/1990
Regulation Medical Specialty: Neurology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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