The following data is part of a premarket notification filed by Nu-gyn-tek, Inc. with the FDA for Poly-op (tm).
| Device ID | K900759 |
| 510k Number | K900759 |
| Device Name: | POLY-OP (TM) |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief |
| Applicant | NU-GYN-TEK, INC. P.O. BOX 75 Oakfield, NY 14125 |
| Contact | Jaeger, M.d. |
| Correspondent | Jaeger, M.d. NU-GYN-TEK, INC. P.O. BOX 75 Oakfield, NY 14125 |
| Product Code | OCF |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-05-24 |