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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K042495
Device Name CUMULASE
Applicant
Halozyme Therapeutics, Inc.
11588 Sorrento Valley Rd. #17
San Diego,  CA  92121
Applicant Contact DON KENNARD
Correspondent
Halozyme Therapeutics, Inc.
11588 Sorrento Valley Rd. #17
San Diego,  CA  92121
Correspondent Contact DON KENNARD
Regulation Number884.6180
Classification Product Code
MQL  
Date Received09/14/2004
Decision Date 04/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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