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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Sterilizer, Steam
510(k) Number K882465
Device Name MODEL 172-P AND 172-N ROTARY SPRAY ARM
Applicant
BOLING PRECISION COMPONENTS CO.
4719 THOMPSON RD.
FORT WAYNE,  IN  46816
Applicant Contact ROBERT BOLING
Correspondent
BOLING PRECISION COMPONENTS CO.
4719 THOMPSON RD.
FORT WAYNE,  IN  46816
Correspondent Contact ROBERT BOLING
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/15/1988
Decision Date 06/24/1988
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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