Laminaria - Biocompatibility Study?

sherley13

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#1
Laminaria it is Ocean Kelp dried and cut to 60mm size and classified by mm thickness size. It is a natural product of vegetable origin. Being a Class 2 Device by FDA and by Medical Device Directives of the European Union, we are required to study the BIOCOMPATIBILITY when it remains inserted in the female cervix for 12-24 hrs to dilate the cervix for carrying out examination of the uterus.

DOES THIS PRODUCT NEED FOR BIO COMPATIBILITY STUDY ????

IF ANY ARTICLES ON LAMINARIA BIOCOMPATIBILITY STUDY OR GUIDELINES OR PROCEDURE AVAILABLE ON THIS PLEASE SHARE WITH ME.

Regards,
Sherley13:agree:
 
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