The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Pasteurmatic System.
Device ID | K953645 |
510k Number | K953645 |
Device Name: | OLYMPIC PASTEURMATIC SYSTEM |
Classification | Device, Pasteurization, Hot Water |
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 | LDS |
CFR Regulation Number | 880.6991 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-04 |
Decision Date | 1995-09-22 |