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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Scale, Patient
510(k) Number K926174
Device Name MODEL 9100 H.R. INFANT SCALE
Applicant
Acme Medical Scale Co.
1801 Adams Ave.
P.O. Box 1922
San Leandro,  CA  94577
Applicant Contact LOU BURAN
Correspondent
Acme Medical Scale Co.
1801 Adams Ave.
P.O. Box 1922
San Leandro,  CA  94577
Correspondent Contact LOU BURAN
Regulation Number880.2720
Classification Product Code
FRW  
Date Received12/08/1992
Decision Date 10/25/1993
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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