The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Pipet Curet.
| Device ID | K001545 |
| 510k Number | K001545 |
| Device Name: | PIPET CURET |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | MILEX PRODUCTS, INC. 4311 NORTH NORMANDY AVE. Chicago, IL 60634 |
| Contact | Cara Furlong |
| Correspondent | Cara Furlong MILEX PRODUCTS, INC. 4311 NORTH NORMANDY AVE. Chicago, IL 60634 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-18 |
| Decision Date | 2000-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937011144 | K001545 | 000 |
| 20888937003554 | K001545 | 000 |
| 20888937003547 | K001545 | 000 |
| 20888937003530 | K001545 | 000 |
| 20888937003523 | K001545 | 000 |
| 20888937003516 | K001545 | 000 |
| 20888937003509 | K001545 | 000 |