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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837110
Device Name MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM
Applicant
Bio Quantum Technologies, Inc.
10315 S. Progress Way
Parker,  CO  80134
Correspondent
Bio Quantum Technologies, Inc.
10315 S. Progress Way
Parker,  CO  80134
Date Received01/07/1983
Decision Date 03/11/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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