510(k) K760849
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1976
- Date Received
- October 15, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Specula, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type