The following data is part of a premarket notification filed by Kinetic Medical Products with the FDA for Fixed-size Uterine Dilator.
| Device ID | K890377 |
| 510k Number | K890377 |
| Device Name: | FIXED-SIZE UTERINE DILATOR |
| Classification | Dilator, Cervical, Fixed Size |
| Applicant | KINETIC MEDICAL PRODUCTS 4934 PEACH ST. Erie, PA 16509 |
| Contact | James I Laughner |
| Correspondent | James I Laughner KINETIC MEDICAL PRODUCTS 4934 PEACH ST. Erie, PA 16509 |
| Product Code | HDQ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-02-13 |