510(k) K823293
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1983
- Date Received
- November 5, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type