FDA 510(k) Application Details - K961219

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K961219
Device Name Unit, Cryosurgical, Accessories
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact Lorraine M Hanley
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 03/28/1996
Decision Date 06/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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