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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Endoscopic, Without Audio
510(k) Number K923160
FOIA Releasable 510(k) K923160
Device Name 3DSCOPE
Applicant
American Surgical Technologies Corp.
88 Essex St.
Haverhiill,  MA  01832
Applicant Contact P.FALLON III
Correspondent
American Surgical Technologies Corp.
88 Essex St.
Haverhiill,  MA  01832
Correspondent Contact P.FALLON III
Regulation Number878.4160
Classification Product Code
FWF  
Date Received06/29/1992
Decision Date 12/10/1992
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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