510(k) K820641
K820641 is an FDA 510(k) premarket notification submitted by Axcan Scientific Corp. for the device "ACCURETTE". The FDA issued a decision of Substantially Equivalent on Jun 22, 1982. The device falls under product code HFF (Aspirator, Endometrial), a Class II device regulated under 21 CFR 884.1060. Axcan Scientific Corp. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 1982
- Date Received
- Mar 8, 1982
- 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
- 510(k)