The following data is part of a premarket notification filed by Rightmedical Products, Llc with the FDA for Rs-1000 Zoom Slitlamp With Option.
Device ID | K060869 |
510k Number | K060869 |
Device Name: | RS-1000 ZOOM SLITLAMP WITH OPTION |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | RIGHTMEDICAL PRODUCTS, LLC 200 EXPRESSWAY COURT Virginia Beach, VA 23462 |
Contact | Harumi Kumahara |
Correspondent | Harumi Kumahara RIGHTMEDICAL PRODUCTS, LLC 200 EXPRESSWAY COURT Virginia Beach, VA 23462 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-30 |
Decision Date | 2006-05-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04562230691848 | K060869 | 000 |
04562230691817 | K060869 | 000 |
04562230691756 | K060869 | 000 |
04562230691640 | K060869 | 000 |