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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryotherapy, Ophthalmic
510(k) Number K854411
Device Name KEELER-COMPACT CRYO SYSTEM
Applicant
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact VAN ARSDALE
Correspondent
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact VAN ARSDALE
Regulation Number886.4170
Classification Product Code
HQA  
Date Received11/01/1985
Decision Date 12/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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