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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 K981999
Device Name ALBATECH PERSONAL MONITOR
Applicant
Albatech, Inc.
4700 Sheridan St.
Bldg. J
Hollywood,  FL  33021
Applicant Contact SHERYL S NATELSON
Correspondent
Albatech, Inc.
4700 Sheridan St.
Bldg. J
Hollywood,  FL  33021
Correspondent Contact SHERYL S NATELSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/08/1998
Decision Date 09/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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