K-number	K941012
Device name	LOW PRESSURE TAMPONADE BALLOON CATHETER
Applicant	Applied Medical Resources
Product code	EYB
Device class	Class II
Decision date	Apr 18, 1994
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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LOW PRESSURE TAMPONADE BALLOON CATHETER

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