The following data is part of a premarket notification filed by American Medical Devices, Inc. with the FDA for Endoview Spphire Lens Set.
| Device ID | K971853 |
| 510k Number | K971853 |
| Device Name: | ENDOVIEW SPPHIRE LENS SET |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| 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 | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-20 |
| Decision Date | 1997-08-06 |
| Summary: | summary |