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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K811390
Device Name CCS100 CRYOSURGICAL SYSTEM
Applicant
FRIGITRONICS OF CONNECTICUT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
FRIGITRONICS OF CONNECTICUT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/18/1981
Decision Date 06/16/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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