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FDA 510(k) Application Details - K971064
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K971064
Device Name
Unit, Phacofragmentation
Applicant
VISION CARE DEVICES, INC.
1246 REDWOOD BLVD.
REDDING, CA 96003 US
Other 510(k) Applications for this Company
Contact
CHET CRACCHIOLO
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
03/24/1997
Decision Date
06/09/1997
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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