The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for 3x Blue Panoramic Loupes 13.5 Working Distance.
| Device ID | K861749 |
| 510k Number | K861749 |
| Device Name: | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE |
| Classification | Loupe, Diagnostic/surgical |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | FSP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-05-23 |