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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irrigator, Sinus
510(k) Number K931398
Device Name GM SWIVEL VIDEO (TM) IRRIGATOR
Applicant
Gm Engineering, Inc.
2549 Sierra Way, Suite B
La Verne,  CA  91750
Applicant Contact DAVID STEFFIN
Correspondent
Gm Engineering, Inc.
2549 Sierra Way, Suite B
La Verne,  CA  91750
Correspondent Contact DAVID STEFFIN
Regulation Number874.4420
Classification Product Code
KAR  
Date Received03/19/1993
Decision Date 08/30/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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