The following data is part of a premarket notification filed by Paragon Medical, Inc. with the FDA for Advanced Imaging Modality (aim) Sterilization Tray, Endoscope And Camera Sterilization Tray, Camera Sterilization Tray.
| Device ID | K152951 |
| 510k Number | K152951 |
| Device Name: | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope And Camera Sterilization Tray, Camera Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | PARAGON MEDICAL, INC. 8 MATCHETT INDUSTRIAL PARK DRIVE Pierceton, IN 46562 |
| Contact | Mike Gosmeyer |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-10-06 |
| Decision Date | 2015-12-28 |