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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 K951090
Device Name INTRODUCER
Applicant
Ranfac, Corp.
30 Doherty Ave., P.O. Box 635
Avon Industrial Park
Avon,  MA  02322
Applicant Contact RAYMOND D LANGLEY
Correspondent
Ranfac, Corp.
30 Doherty Ave., P.O. Box 635
Avon Industrial Park
Avon,  MA  02322
Correspondent Contact RAYMOND D LANGLEY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/09/1995
Decision Date 07/11/1995
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
Predetermined Change
Control Plan Authorized		 No
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