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Table 19 Intracutaneous reactivity results

From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®

Group

24 h after injection

48 h after injection

72 h after injection

Total Primary Irritation Score

Average Erythema

Average Oedema

Average Erythema

Average Oedema

Average Erythema

Average Oedema

4SEAL® - Sodium Chloride

0

0

0

0

0

0

0

Solvent control - Sodium Chloride

0

0

0

0

0

0

0

4SEAL® - Cottonseed oil

0

0

0

0

0

0

0

Solvent control - Cottonseed oil

0

0

0

0

0

0

0