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FDA 510(k) Application Details - K980100
Device Classification Name
Tubing, Replacement, Phacofragmentation Unit
More FDA Info for this Device
510(K) Number
K980100
Device Name
Tubing, Replacement, Phacofragmentation Unit
Applicant
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS, MO 63122-6694 US
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Contact
PATRICK G BALSMANN
Other 510(k) Applications for this Contact
Regulation Number
886.4150
More FDA Info for this Regulation Number
Classification Product Code
MSR
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More FDA Info for this Product Code
Date Received
01/12/1998
Decision Date
06/01/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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