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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumoperitoneum Needle
510(k) Number K970788
Device Name PNEUMO-MATIC INSUFFLATION NEEDLE
Applicant
APPLE MEDICAL CORP.
580 MAIN ST.
BOLTON,  MA  01740
Applicant Contact ROBERT W SCHAEFER
Correspondent
APPLE MEDICAL CORP.
580 MAIN ST.
BOLTON,  MA  01740
Correspondent Contact ROBERT W SCHAEFER
Regulation Number876.1500
Classification Product Code
FHO  
Date Received03/04/1997
Decision Date 03/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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