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 |