510(k) K900759
- Device
- POLY-OP (TM)
- Applicant
- NU-GYN-TEK, INC.
- 510(k) number
- K900759
- Product code
- OCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-05-24
- Date received
- 1990-02-16
- Regulation
- 882.5890
- Classification name
- Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAEGER, M.D.
- Address
- P.O. Box 75 Oakfield NY US 14125 14125
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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