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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractor, Vacuum, Fetal
510(k) Number K013460
Device Name SWIFT LOW PROFILE CUP (PRO CUP)
Applicant
SWIFT DELIVERY PRODUCTS
6824 ELK CANYON RD.
OKLAHOMA CITY,  OK  73162
Applicant Contact RICHARD G LINDSAY
Correspondent
SWIFT DELIVERY PRODUCTS
6824 ELK CANYON RD.
OKLAHOMA CITY,  OK  73162
Correspondent Contact RICHARD G LINDSAY
Regulation Number884.4340
Classification Product Code
HDB  
Date Received10/18/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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