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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K933319
Device Name BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
Applicant
Birtcher Medical Systems, Inc.
41 Brooks Dr.
Braintree,  MA  02184
Applicant Contact EILEEN M ANDERSON
Correspondent
Birtcher Medical Systems, Inc.
41 Brooks Dr.
Braintree,  MA  02184
Correspondent Contact EILEEN M ANDERSON
Regulation Number878.4680
Classification Product Code
GCY  
Date Received07/07/1993
Decision Date 10/27/1993
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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