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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K872446
Device Name MODIFIED INSTAFIL
Applicant
Instafil, Inc.
17941 Sky Park Cir. Suite E
Irvine,  CA  92714
Applicant Contact WILLIAM W SARDAM
Correspondent
Instafil, Inc.
17941 Sky Park Cir. Suite E
Irvine,  CA  92714
Correspondent Contact WILLIAM W SARDAM
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/23/1987
Decision Date 08/25/1987
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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