The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Warmette.
| Device ID | K971117 | 
| 510k Number | K971117 | 
| Device Name: | WARMETTE | 
| Classification | Warmer, Irrigation Solution | 
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 | 
| Contact | Joseph P Stefanile | 
| Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 | 
| Product Code | LHC | 
| CFR Regulation Number | 890.5950 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1997-03-27 | 
| Decision Date | 1997-08-22 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  WARMETTE  78866041  3208889 Live/Registered | NATUS MEDICAL INCORPORATED 2006-04-20 |