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FDA 510(k) Application Details - K964289
Device Classification Name
Specula, Ophthalmic
More FDA Info for this Device
510(K) Number
K964289
Device Name
Specula, Ophthalmic
Applicant
EYEFIX, INC.
12300 TWINBROOK PKWY.
ROCKVILLE, MD 20852 US
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Contact
RICHARD E LIPPMAN
Other 510(k) Applications for this Contact
Regulation Number
886.4350
More FDA Info for this Regulation Number
Classification Product Code
HNC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/1996
Decision Date
12/17/1996
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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