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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K881825
Device Name MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
Applicant
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ROBERT L LEAVITT
Correspondent
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ROBERT L LEAVITT
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/29/1988
Decision Date 09/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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