The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Light-warm.
Device ID | K896611 |
510k Number | K896611 |
Device Name: | OLYMPIC LIGHT-WARM |
Classification | Device, Medical Examination, Ac Powered |
Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Contact | Jay Jones |
Correspondent | Jay Jones OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Product Code | KZF |
CFR Regulation Number | 880.6320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-21 |
Decision Date | 1990-02-06 |