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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 K930611
Device Name TRUE FLOW(TM) VALVE
Applicant
Gm Engineering, Inc.
2549 Sierra Way, Suite B
La Verne,  CA  91750
Applicant Contact DENNY E MILES
Correspondent
Gm Engineering, Inc.
2549 Sierra Way, Suite B
La Verne,  CA  91750
Correspondent Contact DENNY E MILES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/05/1993
Decision Date 12/01/1993
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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