The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Gemini Surgical Light.
| Device ID | K880198 |
| 510k Number | K880198 |
| Device Name: | GEMINI SURGICAL LIGHT |
| Classification | Light, Surgical, Floor Standing |
| Applicant | AMERICAN STERILIZER CO. 2222 WEST GRANDVIEW BLVD. Erie, PA 16512 |
| Contact | James A Spallina |
| Correspondent | James A Spallina AMERICAN STERILIZER CO. 2222 WEST GRANDVIEW BLVD. Erie, PA 16512 |
| Product Code | FSS |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-15 |
| Decision Date | 1988-02-10 |