The following data is part of a premarket notification filed by Getinge Sourcing, Llc with the FDA for Getinge 400hc/500hc Series Steam Sterilizer.
| Device ID | K103504 |
| 510k Number | K103504 |
| Device Name: | GETINGE 400HC/500HC SERIES STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | GETINGE SOURCING, LLC 1777 EAST HENRIETTA ROAD Rochester, NY 14623 |
| Contact | Barb Smith |
| Correspondent | Barb Smith GETINGE SOURCING, LLC 1777 EAST HENRIETTA ROAD Rochester, NY 14623 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-03-16 |
| Summary: | summary |