510(k) K790526
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1979
- Date Received
- March 15, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Condensing, Diagnostic
- Device Class
- Class I
- Regulation Number
- 886.1380
- Review Panel
- OP
- Submission Type