K-number	K802247
Device name	BOUNDARY SINGLE-USE DRAPES
Applicant	Procter & Gamble Mfg. Co.
Product code	KKX
Device class	Class II
Decision date	Sep 26, 1980
Decision	Substantially Equivalent
Regulation	878.4370

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View the full FDA submission: accessdata.fda.gov

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BOUNDARY SINGLE-USE DRAPES

Everything you need for a 510(k) submission. Nothing you don't.