FDA 510K is listed for The All American Autoclave is FDA 510 listed becasue it was manufactured prior to May 28 th , 1976
Back to ordering now the All American Autocalve 25X

• The All American Steam Autoclaves are registered and listed with the FDA but not approved as per FDA code # 807.85 "Exemption from Premarket Notification"
Click here to see the FDA statement

• There is no need for the 510K FDA approvals for “Wisconsin Aluminum Foundry Inc” which
is also called “The All American Sterilizer”. This is because according to the FDA rulings, these sterilizers were manufactured and commercially distributed before May 28, 1976 and did not require Pre Mark et Approvals.

• The FDA clause regarding this can be found in Subpart E Premarket Notification Procedures Section 807.85 Exemption from pre market notification in Section 1
Click here to see the FDA Premarket Notification Procedure

• One of the ways to prove that the sterilizer was manufactured and distributed before May 28, 1976
is to show the catalog pages, promotional material with dates prior to May 28, 1976 .
Here is a copy of the catalog of this sterilizer with dates prior to MAY 28,1976

Please call if you have a need for further assistance 1-800-801-9934

Alfa Medical