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FDA 510(k) Application Details - K981235
Device Classification Name
Specula, Ophthalmic
More FDA Info for this Device
510(K) Number
K981235
Device Name
Specula, Ophthalmic
Applicant
LASER CENTER DEV. CORP.
1028 S. KIRKWOOD RD.
SUITE A
ST. LOUIS, MO 63122-7222 US
Other 510(k) Applications for this Company
Contact
FRANCIS E O'DONNELL
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
04/03/1998
Decision Date
07/15/1998
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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