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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K864946
Device Name ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
Applicant
BIO QUANTUM TECHNOLOGIES, INC.
8275 EL RIO, STE. 180
HOUSTON,  TX  77054
Applicant Contact JOYCE HEINRICH
Correspondent
BIO QUANTUM TECHNOLOGIES, INC.
8275 EL RIO, STE. 180
HOUSTON,  TX  77054
Correspondent Contact JOYCE HEINRICH
Regulation Number884.4550
Classification Product Code
HHR  
Date Received12/17/1986
Decision Date 01/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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