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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 K991393
Device Name HYALURONIDASE, 80 U/ML
Applicant
Sage Biopharma
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Sage Biopharma
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/21/1999
Decision Date 02/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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