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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 K970170
Device Name SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
Applicant
RICHARD G. LINDSAY
6824 ELK CANYON RD.
OKLAHOMA CITY,  OK  73162
Applicant Contact RICHARD G LINDSAY
Correspondent
RICHARD G. LINDSAY
6824 ELK CANYON RD.
OKLAHOMA CITY,  OK  73162
Correspondent Contact RICHARD G LINDSAY
Regulation Number884.4340
Classification Product Code
HDB  
Date Received01/09/1997
Decision Date 03/28/1997
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
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