510(k) K831669
K831669 is an FDA 510(k) premarket notification submitted by Axcan Scientific Corp. for the device "AXCAN SPERM CUP". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Axcan Scientific Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1983
- Date Received
- May 23, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Cervical
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type