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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, umbilical
510(k) Number K933763
Device Name SAVE-T-BREATH AMBILICAL CORD CLAMP
Applicant
SAVE-T-BREATH DISTRIBUTORS C.C.
P.O.BOX 87523
HOUGHTON 2041
SOUTH AFRICA,  ZA
Applicant Contact C. NATES
Correspondent
SAVE-T-BREATH DISTRIBUTORS C.C.
P.O.BOX 87523
HOUGHTON 2041
SOUTH AFRICA,  ZA
Correspondent Contact C. NATES
Regulation Number884.4530
Classification Product Code
HFW  
Date Received08/03/1993
Decision Date 08/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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