The following data is part of a premarket notification filed by Getinge Sourcing Llc with the FDA for Getinge 633hc Steam Sterilizer Air Glide System.
| Device ID | K120532 |
| 510k Number | K120532 |
| Device Name: | GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM |
| Classification | Sterilizer Automated Loading System |
| Applicant | GETINGE SOURCING LLC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Contact | Barb Smith |
| Correspondent | Barb Smith GETINGE SOURCING LLC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Product Code | PEC |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-22 |
| Decision Date | 2013-05-02 |
| Summary: | summary |