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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 K930474
Device Name NEEDLE, PNEUMOPERITONEUM, SPRING LOADED
Applicant
RANFAC CORP.
30 DOHERTY AVE., P.O. BOX 635
AVON INDUSTRIAL PARK
AVON,  MA  02322
Applicant Contact JOHN P SBARDELLI
Correspondent
RANFAC CORP.
30 DOHERTY AVE., P.O. BOX 635
AVON INDUSTRIAL PARK
AVON,  MA  02322
Correspondent Contact JOHN P SBARDELLI
Regulation Number876.1500
Classification Product Code
FHO  
Subsequent Product Code
GCJ  
Date Received01/28/1993
Decision Date 07/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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