The following data is part of a premarket notification filed by Technology Delivery Systems, Inc. with the FDA for Maxiflex-semi Flex Scope.
| Device ID | K062725 |
| 510k Number | K062725 |
| Device Name: | MAXIFLEX-SEMI FLEX SCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | TECHNOLOGY DELIVERY SYSTEMS, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2006-09-29 |
| Summary: | summary |