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510(k) K032087

KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 by Keeler Instruments, Inc. — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2003
Date Received
July 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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