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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name douche apparatus, vaginal, therapeutic
510(k) Number K902830
Device Name PERI-BOTTLE
Applicant
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Applicant Contact JOHN L LAEMMAR
Correspondent
ORION LIFE SYSTEMS, INC.
124 MESSNER DR.
WHEELING,  IL  60090
Correspondent Contact JOHN L LAEMMAR
Regulation Number884.5900
Classification Product Code
HED  
Date Received06/28/1990
Decision Date 08/06/1990
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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