510(k) K831212
K831212 is an FDA 510(k) premarket notification submitted by Axcan Scientific Corp. for the device "ENDOSCANN". The FDA issued a decision of Substantially Equivalent on June 15, 1984. The device falls under product code HFF (Aspirator, Endometrial), a Class II device regulated under 21 CFR 884.1060. Axcan Scientific Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1984
- Date Received
- April 14, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aspirator, Endometrial
- Device Class
- Class II
- Regulation Number
- 884.1060
- Review Panel
- OB
- Submission Type