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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Surgical, Cryogenic
510(k) Number K831963
Device Name CRYOMEDICS NEUROSTAT
Applicant
SPEMBLY MEDICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SPEMBLY MEDICAL LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.4250
Classification Product Code
GXH  
Date Received06/17/1983
Decision Date 08/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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