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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K934089
Device Name BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S
Applicant
Bio Quantum Technologies, Inc.
10315 S. Progress Way
Parker,  CO  80134
Applicant Contact SCOTT A TEUBER
Correspondent
Bio Quantum Technologies, Inc.
10315 S. Progress Way
Parker,  CO  80134
Correspondent Contact SCOTT A TEUBER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/24/1993
Decision Date 02/03/1994
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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