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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K854256
Device Name KEELER AMOILS SURGICAL ASTIGOMETER
Applicant
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact VAN ARSDAL
Correspondent
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact VAN ARSDAL
Date Received10/22/1985
Decision Date 12/13/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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