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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter And Tip, Suction
510(k) Number K831999
Device Name FEMORAL CANAL SUCTION TAMPON
Applicant
RICHARDS MANUFACTURER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARDS MANUFACTURER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6740
Classification Product Code
JOL  
Date Received06/21/1983
Decision Date 09/29/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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