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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal
510(k) Number K894220
Device Name HOUTS HYSTERECTOMY DRAIN
Applicant
Helix Medical, Inc.
210 Santa Barbera St.
Santa Barbera,  CA  93101
Applicant Contact CHRISTINE EMANUEL
Correspondent
Helix Medical, Inc.
210 Santa Barbera St.
Santa Barbera,  CA  93101
Correspondent Contact CHRISTINE EMANUEL
Regulation Number878.4200
Classification Product Code
GBW  
Date Received06/19/1989
Decision Date 08/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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