510(k) K873795
K873795 is an FDA 510(k) premarket notification submitted by Opto Vision, Inc. for the device "M-LENS (THIRTY DEGREE ENDOSCOPE)". The FDA issued a decision of Substantially Equivalent on January 14, 1988. The device falls under product code FEI (Instrument, Special Lens, For Endoscope), a Class I device regulated under 21 CFR 876.1500. Opto Vision, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1988
- Date Received
- September 17, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Special Lens, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type