The following data is part of a premarket notification filed by Rightmedical Products, Llc with the FDA for Righton Zoom Slit Lamp Microscope With Photo Option.
Device ID | K110129 |
510k Number | K110129 |
Device Name: | RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | RIGHTMEDICAL PRODUCTS, LLC 1430 BIRCHMOUNT ROAD Toronto, Ontario, CA M1p 2e8 |
Contact | Melanie Deslauriers |
Correspondent | Melanie Deslauriers RIGHTMEDICAL PRODUCTS, LLC 1430 BIRCHMOUNT ROAD Toronto, Ontario, CA M1p 2e8 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-18 |
Decision Date | 2011-08-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04562230698991 | K110129 | 000 |
04562230697062 | K110129 | 000 |
04562230695112 | K110129 | 000 |
04562230695051 | K110129 | 000 |
04562230694429 | K110129 | 000 |
04562230694375 | K110129 | 000 |
04580606431584 | K110129 | 000 |
04580606431553 | K110129 | 000 |
04580606431522 | K110129 | 000 |
04562230697109 | K110129 | 000 |
04562230697123 | K110129 | 000 |
04562230697161 | K110129 | 000 |
04562230698984 | K110129 | 000 |
04562230698977 | K110129 | 000 |
04562230698960 | K110129 | 000 |
04562230698953 | K110129 | 000 |
04562230698946 | K110129 | 000 |
04562230698939 | K110129 | 000 |
04562230698922 | K110129 | 000 |
04562230697192 | K110129 | 000 |
04580606431492 | K110129 | 000 |