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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Obstetric (And Accessories)
510(k) Number K852171
Device Name CAT. NO. S-5300-E BIRTHING BED
Applicant
Shampaine/Wilson
1920 S. Jefferson Ave.
St. Louis,  MO  63104
Applicant Contact KEVIN RANDICH
Correspondent
Shampaine/Wilson
1920 S. Jefferson Ave.
St. Louis,  MO  63104
Correspondent Contact KEVIN RANDICH
Regulation Number884.4900
Classification Product Code
KNC  
Date Received05/20/1985
Decision Date 08/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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