K-number	K833859
Device name	TAMPONADE BALLOON CUFF
Applicant	American Endoscopy, Inc.
Product code	GCP
Device class	Class II
Decision date	Jan 3, 1984
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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TAMPONADE BALLOON CUFF

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