FDA 510(k) Application Details - K952334

Device Classification Name Kit, Wound Dressing

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510(K) Number K952334
Device Name Kit, Wound Dressing
Applicant BUSSE HOSPITAL DISPOSABLES, INC.
75 ARKAY DR.
HAUPPAUGE, NY US
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Contact EILEEN RAMA
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Regulation Number 000.0000

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Classification Product Code MCY
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Date Received 05/18/1995
Decision Date 07/14/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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