510(k) K960007
K960007 is an FDA 510(k) premarket notification submitted by Storz for the device "STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR". The FDA issued a decision of Substantially Equivalent on March 26, 1996. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Storz has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1996
- Date Received
- January 2, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoilluminator
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- OP
- Submission Type