The following data is part of a premarket notification filed by Getinge Sourcing Llc with the FDA for Getinge 800hc- Series Steam Sterilizer.
| Device ID | K122625 |
| 510k Number | K122625 |
| Device Name: | GETINGE 800HC- SERIES STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| 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 | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-28 |
| Decision Date | 2013-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05902533511792 | K122625 | 000 |
| 05902533505524 | K122625 | 000 |
| 05902533505548 | K122625 | 000 |
| 05902533505579 | K122625 | 000 |
| 05902533505593 | K122625 | 000 |
| 05902533505609 | K122625 | 000 |
| 05902533505616 | K122625 | 000 |
| 05902533505647 | K122625 | 000 |
| 05902533505654 | K122625 | 000 |
| 05902533511273 | K122625 | 000 |
| 05902533511198 | K122625 | 000 |
| 05902533511808 | K122625 | 000 |
| 05902533511761 | K122625 | 000 |
| 05902533511778 | K122625 | 000 |
| 05902533511716 | K122625 | 000 |
| 05902533511693 | K122625 | 000 |
| 05902533511709 | K122625 | 000 |
| 05902533511532 | K122625 | 000 |
| 05902533511358 | K122625 | 000 |
| 05902533505661 | K122625 | 000 |
| 05902533505678 | K122625 | 000 |
| 05902533505692 | K122625 | 000 |
| 05902533510429 | K122625 | 000 |
| 05902533510641 | K122625 | 000 |
| 05902533510658 | K122625 | 000 |
| 05902533510665 | K122625 | 000 |
| 05902533510740 | K122625 | 000 |
| 05902533510757 | K122625 | 000 |
| 05902533510764 | K122625 | 000 |
| 05902533510856 | K122625 | 000 |
| 05902533510344 | K122625 | 000 |
| 05902533510313 | K122625 | 000 |
| 05902533505715 | K122625 | 000 |
| 05902533505739 | K122625 | 000 |
| 05902533510092 | K122625 | 000 |
| 05902533510160 | K122625 | 000 |
| 05902533510191 | K122625 | 000 |
| 05902533510252 | K122625 | 000 |
| 05902533510269 | K122625 | 000 |
| 05902533510290 | K122625 | 000 |
| 05902533510863 | K122625 | 000 |