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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K925041
Device Name MCKERNAN ATRAUMATIC FORCEPS
Applicant
Aslan Medical Technologies, Ltd.
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Applicant Contact DOUGLAS DONALDSON
Correspondent
Aslan Medical Technologies, Ltd.
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Correspondent Contact DOUGLAS DONALDSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/05/1992
Decision Date 11/25/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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