The following data is part of a premarket notification filed by Nu-gyn-tek, Inc. with the FDA for The D & C Pad-sac.
| Device ID | K862297 |
| 510k Number | K862297 |
| Device Name: | THE D & C PAD-SAC |
| Classification | Curette, Uterine |
| 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 | HCY |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-17 |
| Decision Date | 1986-07-07 |