Document LpByg0zRVeagbxbwDroJnq9a5

/)/U^ ?/ M August 8, 1989 Henry Forsyth Avon Lake Tech Center SUBJECT: EXPERIMENTAL CONTACT LENS MOLD COMPOUND There are no FDA regulations that generally list what substances may be used to make medical devices. Device manufacturers often rely on the use of substances that are permitted to be used on contact with food. Compound 165-37-139-17 is composed of only ingredients which are permitted for use in contact with food. The ingredients in compound 165-37-139-17 are either listed on a regulation under 21CFR, or are generally recognized as safe or prior sanctioned for use in food contact articles. W. C. Bachtel 90808-3/jp cc: M. Miller - ALTC C. Purks - ALTC BFG18920 22117001