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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Urethral
510(k) Number K924440
Device Name U.S. MEDICAL PS-7000 DIALYSIS SCALE
Applicant
U.S. Medical Corp.
12 Scovil Rd.
Higgaum,  CT  06441
Applicant Contact BRUCE E DODSON
Correspondent
U.S. Medical Corp.
12 Scovil Rd.
Higgaum,  CT  06441
Correspondent Contact BRUCE E DODSON
Regulation Number876.5520
Classification Product Code
KOE  
Date Received09/01/1992
Decision Date 05/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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