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FDA 510(k) Application Details - K973633
Device Classification Name
Lacrimal Stents And Intubation Sets
More FDA Info for this Device
510(K) Number
K973633
Device Name
Lacrimal Stents And Intubation Sets
Applicant
ATRION MEDICAL PRODUCTS, INC.
1426 CURT FRANCIS RD.
ARAB, AL 35016 US
Other 510(k) Applications for this Company
Contact
DAN CLARK
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
OKS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/1997
Decision Date
01/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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