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FDA 510(k) Application Details - K955158
Device Classification Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
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510(K) Number
K955158
Device Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
Applicant
ELLMAN INTL., INC.
30 NORTHPORT RD.
SOUND BEACH, NY 11789-1734 US
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Contact
RICHARD C LANZILLOTTO
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Regulation Number
886.4100
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Classification Product Code
HQR
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More FDA Info for this Product Code
Date Received
11/13/1995
Decision Date
02/09/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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