Substantially Equivalent 510(k) Device Information
Applicant: Alpha Scientific Corp., Southeastern, PA
510(k) number: BK940054
Product: SEG-SAFE
Date: 3/15/95
Summary of Safety and Effectiveness
IN RESPONSE TO THE SAFE MEDICAL DEVICES ACT OF 1990, THE FOLLOWING IS A STATEMENT THAT:
Safety and Effectiveness information regarding the SEG-SAFE™ which provides the basic for a substantial equivalence finding, will be kept in the files of Alpha Scientific Corp., and will be made available to any interested person upon request.
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