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FDA 510(k) Application Details - K961658
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K961658
Device Name
Unit, Phacofragmentation
Applicant
INTL. OPHTHALMIC INDUSTRIES CORP.
344 ANNABELLE POINT RD.
P.O. BOX 628
CENTERVILLE, MA 02632 US
Other 510(k) Applications for this Company
Contact
HILLARD W WELCH
Other 510(k) Applications for this Contact
Regulation Number
886.4670
More FDA Info for this Regulation Number
Classification Product Code
HQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/29/1996
Decision Date
07/23/1996
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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