510(k) K782054
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1979
- Date Received
- December 7, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Surgical, Gynecologic
- Device Class
- Class II
- Regulation Number
- 884.4550
- Review Panel
- OB
- Submission Type