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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K933848
Device Name PRESPO 7, SELF-SUFFICIENT DRIP DEVICE
Applicant
Bonding Corp.
429 Moon Clinton Rd.
Coraopolis,  PA  15108
Applicant Contact JEAN-PIERRE LA RUDULIER
Correspondent
Bonding Corp.
429 Moon Clinton Rd.
Coraopolis,  PA  15108
Correspondent Contact JEAN-PIERRE LA RUDULIER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/06/1993
Decision Date 03/03/1995
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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