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FDA 510(k) Application Details - K011195
Device Classification Name
Keratome, Ac-Powered
More FDA Info for this Device
510(K) Number
K011195
Device Name
Keratome, Ac-Powered
Applicant
SURGIN SURGICAL INSTRUMENTATION, INC.
14762 BENTLEY CIRCLE
TUSTIN, CA 92680 US
Other 510(k) Applications for this Company
Contact
DON HAAR
Other 510(k) Applications for this Contact
Regulation Number
886.4370
More FDA Info for this Regulation Number
Classification Product Code
HNO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/19/2001
Decision Date
11/06/2001
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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