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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Needle, Gastroenterologic
510(k) Number K930330
Device Name ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
Applicant
HOLMED CORP.
40 NORFOLK AVE.
SOUTH EASTON,  MA  02375
Applicant Contact RUSSELL P HOLMES
Correspondent
HOLMED CORP.
40 NORFOLK AVE.
SOUTH EASTON,  MA  02375
Correspondent Contact RUSSELL P HOLMES
Regulation Number876.4730
Classification Product Code
FHQ  
Date Received01/22/1993
Decision Date 06/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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