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 |