The following data is part of a premarket notification filed by Multigon Industries, Inc. with the FDA for Doppler Guided Proctoscope, Model 500h.
| Device ID | K052067 |
| 510k Number | K052067 |
| Device Name: | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | MULTIGON INDUSTRIES, INC. ONE ODELL PLAZA Yonkers, NY 10701 |
| Contact | William Stern |
| Correspondent | William Stern MULTIGON INDUSTRIES, INC. ONE ODELL PLAZA Yonkers, NY 10701 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-01 |
| Decision Date | 2005-08-29 |
| Summary: | summary |