510(k) K771181
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1977
- Date Received
- June 30, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Metal, Fiberoptic
- Device Class
- Class I
- Regulation Number
- 884.4520
- Review Panel
- OB
- Submission Type