The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Curelle.
| Device ID | K915491 |
| 510k Number | K915491 |
| Device Name: | CURELLE |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | BIOTEQUE CORP. 5` RAINLILY RD. Levittown, PA 19056 |
| Contact | Denis Dorsey |
| Correspondent | Denis Dorsey BIOTEQUE CORP. 5` RAINLILY RD. Levittown, PA 19056 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-06 |
| Decision Date | 1992-11-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CURELLE 73436408 not registered Dead/Abandoned |
CLAIROL INCORPORATED 1983-07-26 |