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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K900665
Device Name DRESSING CHANGE KIT
Applicant
HEALTHDYNE CARDIOVASCULAR, INC.
45 PARKER ST., SUITE A
IRVINE,  CA  92618 -1658
Applicant Contact BILL WELCH
Correspondent
HEALTHDYNE CARDIOVASCULAR, INC.
45 PARKER ST., SUITE A
IRVINE,  CA  92618 -1658
Correspondent Contact BILL WELCH
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/13/1990
Decision Date 05/14/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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