510(k) K884696
K884696 is an FDA 510(k) premarket notification submitted by Laboratoire Ccd C/O Washington Regulatory Services for the device "RESUBMITTED ARTIFICIAL INSEMINATION INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Laboratoire Ccd C/O Washington Regulatory Services has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1989
- Date Received
- November 9, 1988
- 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