510(k) K904186
K904186 is an FDA 510(k) premarket notification submitted by Site Microsurgical Systems, Inc. for the device "SITE DIAPHRAGM CASSETTE". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code KYG (Device, Irrigation, Ocular Surgery), a Class I device regulated under 21 CFR 886.4360. Site Microsurgical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1990
- Date Received
- September 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Irrigation, Ocular Surgery
- Device Class
- Class I
- Regulation Number
- 886.4360
- Review Panel
- OP
- Submission Type