The following data is part of a premarket notification filed by American Medical Devices, Inc. with the FDA for Endolight Fiberoptic Endo-illuminator (20 Ga. & 19 Ga.).
| Device ID | K970875 |
| 510k Number | K970875 |
| Device Name: | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) |
| Classification | Endoilluminator |
| Applicant | AMERICAN MEDICAL DEVICES, INC. 1100 NORTHSIDE DR. Atlanta, GA 30318 |
| Contact | Frank J Tighe |
| Correspondent | Frank J Tighe AMERICAN MEDICAL DEVICES, INC. 1100 NORTHSIDE DR. Atlanta, GA 30318 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-05-20 |
| Summary: | summary |