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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K864948
Device Name ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
Applicant
Bio Quantum Technologies, Inc.
8275 El Rio, Suite 180
Houston,  TX  77054
Applicant Contact JOYCE HEINRICH
Correspondent
Bio Quantum Technologies, Inc.
8275 El Rio, Suite 180
Houston,  TX  77054
Correspondent Contact JOYCE HEINRICH
Regulation Number878.4810
Classification Product Code
LNK  
Date Received12/17/1986
Decision Date 03/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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