The following data is part of a premarket notification filed by Amsco Co. with the FDA for Amsco Polaris Sl.
| Device ID | K854922 |
| 510k Number | K854922 |
| Device Name: | AMSCO POLARIS SL |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | AMSCO CO. 2424 WEST 23RD ST. Erie, PA 16514 |
| Contact | James A Spallina |
| Correspondent | James A Spallina AMSCO CO. 2424 WEST 23RD ST. Erie, PA 16514 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-10 |
| Decision Date | 1986-01-24 |