510(k) K883480
K883480 is an FDA 510(k) premarket notification submitted by Site Microsurgical Systems, Inc. for the device "MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE". The FDA issued a decision of Substantially Equivalent on August 24, 1988. The device falls under product code FCT (Headlight, Fiberoptic Focusing), a Class II device regulated under 21 CFR 886.4335. Site Microsurgical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1988
- Date Received
- August 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Headlight, Fiberoptic Focusing
- Device Class
- Class II
- Regulation Number
- 886.4335
- Review Panel
- OP
- Submission Type