The following data is part of a premarket notification filed by Propper Manufacturing Co.,inc. with the FDA for Propper Insight Binocular Indirect Ophthalmosope.
| Device ID | K141638 |
| 510k Number | K141638 |
| Device Name: | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | PROPPER MANUFACTURING CO.,INC. 36-04 SKILLMAN AVENUE Long Island City, NY 11101 |
| Contact | Andrew Sharavara |
| Correspondent | Andrew Sharavara PROPPER MANUFACTURING CO.,INC. 36-04 SKILLMAN AVENUE Long Island City, NY 11101 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-19 |
| Decision Date | 2014-09-17 |
| Summary: | summary |