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FDA 510(k) Application Details - K960261
Device Classification Name
Burr, Corneal, Battery-Powered
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510(K) Number
K960261
Device Name
Burr, Corneal, Battery-Powered
Applicant
ALCON LABORATORIES, INC.
520 N. SEMORAN BLVD.
SUITE 180
ORLANDO, FL 32807 US
Other 510(k) Applications for this Company
Contact
S. K MCGARVEY
Other 510(k) Applications for this Contact
Regulation Number
886.4070
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Classification Product Code
HOG
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More FDA Info for this Product Code
Date Received
01/18/1996
Decision Date
03/11/1996
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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