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 |