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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K862949
Device Name HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER
Applicant
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Applicant Contact JAMES A CORMACK
Correspondent
Oscor Medical Corp.
2311 Us Alt. 19n.
P.O. Box 459
Palm Harbor,  FL  33563
Correspondent Contact JAMES A CORMACK
Regulation Number876.5010
Classification Product Code
LQR  
Date Received08/05/1986
Decision Date 10/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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