510(k) K781767
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1978
- Date Received
- October 16, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, General Obstetric-Gynecologic
- Device Class
- Class I
- Regulation Number
- 884.4520
- Review Panel
- OB
- Submission Type