FDA 510(k) Application Details - K971134

Device Classification Name Cup, Eye

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510(K) Number K971134
Device Name Cup, Eye
Applicant JOHN BRANCH
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GRACE HOLLAND
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Regulation Number 000.0000

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Classification Product Code LXQ
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Date Received 03/28/1997
Decision Date 11/04/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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