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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K970916
Device Name H.V. PULSE LAVAGE (L31 SERIES)
Applicant
Global Medical Products, Inc.
1725 S. Rainbow Blvd., #25
Las Vegas,  NV  89146
Applicant Contact TONYA BALABAN
Correspondent
Global Medical Products, Inc.
1725 S. Rainbow Blvd., #25
Las Vegas,  NV  89146
Correspondent Contact TONYA BALABAN
Regulation Number880.5475
Classification Product Code
FQH  
Date Received03/12/1997
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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