The following data is part of a premarket notification filed by Getinge/castle, Inc. with the FDA for Castle Surgical Light, Model 3000.
| Device ID | K993242 |
| 510k Number | K993242 |
| Device Name: | CASTLE SURGICAL LIGHT, MODEL 3000 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | GETINGE/CASTLE, INC. 7371 SPARTAN BLVD E. North Charleston, SC 29418 |
| Contact | Peter L Koste |
| Correspondent | Peter L Koste GETINGE/CASTLE, INC. 7371 SPARTAN BLVD E. North Charleston, SC 29418 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 1999-11-08 |
| Summary: | summary |