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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 K973942
Device Name SWIFT DELIVERY PRODUCT #300
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 Received09/26/1997
Decision Date 12/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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