The following data is part of a premarket notification filed by Frantz Medical Development, Ltd. with the FDA for Endoscopic Accessory To The Light Source.
| Device ID | K905282 |
| 510k Number | K905282 |
| Device Name: | ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
| Contact | Maureen D Roden |
| Correspondent | Maureen D Roden FRANTZ MEDICAL DEVELOPMENT, LTD. 595 MADISON AVE. New York, NY 10022 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-23 |
| Decision Date | 1991-03-19 |