FDA 510(k) Application Details - K960201

Device Classification Name Wrap, Sterilization

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510(K) Number K960201
Device Name Wrap, Sterilization
Applicant GE MEDICAL SYSTEMS
1247 FLORDIA AVE.
PALM HARBOR, FL 34683 US
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Contact PATRICK J LAMB
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 01/16/1996
Decision Date 02/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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