510(k) K830430
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1983
- Date Received
- February 9, 1983
- 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