The following data is part of a premarket notification filed by Rocky Mountain Medical Corp. with the FDA for Babe Shade-infant Ambient Light Intensity Reducer.
| Device ID | K853790 |
| 510k Number | K853790 |
| Device Name: | BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Contact | RICHARD ROSEBAUM |
| Correspondent | RICHARD ROSEBAUM ROCKY MOUNTAIN MEDICAL CORP. 5680 S. SYRACUSE CIRCLE P.O. BOX 4783 GREENWOOD VILLAGE, CO 80111 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-10 |
| Decision Date | 1985-10-04 |