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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 K823835
Device Name SPEMBLY 140 CRYOSYSTEM PROBES & TIPS
Applicant
KELLER INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KELLER INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4170
Classification Product Code
HQA  
Date Received12/21/1982
Decision Date 01/17/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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