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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Syringe, Piston
510(k) Number K930791
Device Name AMERICAN POWER CONVERSIONS, BACK-UPS 600
Applicant
Bio Clinic Co.
4083 E. Airport Dr.
Ontario,  CA  91761
Applicant Contact GREG GODFREY
Correspondent
Bio Clinic Co.
4083 E. Airport Dr.
Ontario,  CA  91761
Correspondent Contact GREG GODFREY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/16/1993
Decision Date 08/06/1993
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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