FDA 510(k) Application Details - K961971

Device Classification Name Light, Surgical, Floor Standing

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510(K) Number K961971
Device Name Light, Surgical, Floor Standing
Applicant Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA, CA 95051-4085 US
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Contact BADER-E BELLAHSENE, PH.D.
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Regulation Number 878.4580

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Classification Product Code FSS
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Date Received 05/20/1996
Decision Date 06/28/1996
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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