Name: Predicase
Price: 199 USD

K-number	K020759
Device name	7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
Applicant	Hans Rudolph, Inc.
Product code	BZD
Device class	Class II
Decision date	Aug 13, 2002
Decision	Substantially Equivalent
Regulation	868.5905

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View the full FDA submission: accessdata.fda.gov

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7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT

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