The following data is part of a premarket notification filed by Axcan Scientific Corp. with the FDA for Accurette.
| Device ID | K820641 |
| 510k Number | K820641 |
| Device Name: | ACCURETTE |
| Classification | Aspirator, Endometrial |
| Applicant | AXCAN SCIENTIFIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HFF |
| CFR Regulation Number | 884.1060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACCURETTE 78157051 not registered Dead/Abandoned |
POLYCORE OPTICAL PTE LTD 2002-08-22 |
![]() ACCURETTE 74017722 1625441 Dead/Cancelled |
Bulova Corporation 1990-01-10 |
![]() ACCURETTE 73353789 1313297 Dead/Cancelled |
Societe D'Importation et D'Exportation de Produits Pharmaceutiques "Axcan Ltee" 1982-03-10 |
![]() ACCURETTE 72183245 0785768 Dead/Expired |
BULOVA WATCH COMPANY, INC. 1963-12-19 |
![]() ACCURETTE 71675568 0612086 Dead/Expired |
MACALASTER BICKNELL PARENTERAL CORPORATION 1954-10-27 |