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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Fluorescein, Ac-Powered
510(k) Number K922348
Device Name VALTRAC(R) INTRODUCER FORCEP
Applicant
American Cyanamid Co.
One Casper St.
Danbury,  CT  06810
Applicant Contact STEPHEN J TAMSETT
Correspondent
American Cyanamid Co.
One Casper St.
Danbury,  CT  06810
Correspondent Contact STEPHEN J TAMSETT
Regulation Number878.4580
Classification Product Code
HJE  
Date Received05/19/1992
Decision Date 06/09/1992
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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