The following data is part of a premarket notification filed by Apple Medical Corp. with the FDA for Ureteral Illuminator.
| Device ID | K941506 |
| 510k Number | K941506 |
| Device Name: | URETERAL ILLUMINATOR |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | APPLE MEDICAL CORP. 93 NASHAWAY RD. Bolton, MA 01740 |
| Contact | R. W Schaefer |
| Correspondent | R. W Schaefer APPLE MEDICAL CORP. 93 NASHAWAY RD. Bolton, MA 01740 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-29 |
| Decision Date | 1994-10-05 |