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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K010754
Device Name NURSE'S ASSISTANT O.R. CONTROL SYSTEM
Applicant
VAL MED CORP.
555 THIRTEENTH ST. N.W.
COLUMBIA SQUARE
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN, ESQ.
Correspondent
VAL MED CORP.
555 THIRTEENTH ST. N.W.
COLUMBIA SQUARE
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN, ESQ.
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
FET   FSY   HET  
Date Received03/13/2001
Decision Date 08/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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