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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 K913810
Device Name HOLMED HAND HELD INSTRUMENTS
Applicant
PERFORMANCE SURGICAL INSTRUMENTS CORP.
600 SOUTH ST.
HOLBROOK,  MA  02343
Applicant Contact RUSSELL HOLMES
Correspondent
PERFORMANCE SURGICAL INSTRUMENTS CORP.
600 SOUTH ST.
HOLBROOK,  MA  02343
Correspondent Contact RUSSELL HOLMES
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/26/1991
Decision Date 12/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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