510(k) K923774
K923774 is an FDA 510(k) premarket notification submitted by O.R. Specialties, Inc. for the device "DISPOSABLE ENDOILLUMINATOR". The FDA issued a decision of Substantially Equivalent on October 19, 1992. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. O.R. Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1992
- Date Received
- July 28, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Carrier, Fiberoptic Light
- Device Class
- Class I
- Regulation Number
- 874.4350
- Review Panel
- EN
- Submission Type