The following data is part of a premarket notification filed by Axcan Scientific Corp. with the FDA for Endoscann.
| Device ID | K831212 |
| 510k Number | K831212 |
| Device Name: | ENDOSCANN |
| 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 | 1983-04-14 |
| Decision Date | 1984-06-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOSCANN 73242401 1162609 Dead/Cancelled |
Arts et Techniques Nouvelles 1979-12-10 |