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 |