The following data is part of a premarket notification filed by Sis Ltd. Surgical Instrument Systems with the FDA for Cm 3910 Rotating Double Scheimpflug Camera.
Device ID | K051940 |
510k Number | K051940 |
Device Name: | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA |
Classification | Device, Analysis, Anterior Segment |
Applicant | SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton, CO 80127 |
Contact | Kevin Walls |
Correspondent | Kevin Walls SIS LTD. SURGICAL INSTRUMENT SYSTEMS 13 RED FOX LANE Littleton, CO 80127 |
Product Code | MXK |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-18 |
Decision Date | 2005-09-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07640167751235 | K051940 | 000 |