The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Amsco Sq240 Surgical Light.
| Device ID | K943288 |
| 510k Number | K943288 |
| Device Name: | AMSCO SQ240 SURGICAL LIGHT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Contact | Michael Zmuda |
| Correspondent | Michael Zmuda AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 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 | 1994-07-08 |
| Decision Date | 1994-10-17 |