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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 K781956
Device Name CRYOSURGICAL DEVICE 2000
Applicant
VALLEYLAB, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VALLEYLAB, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4350
Classification Product Code
GEH  
Date Received11/21/1978
Decision Date 01/10/1979
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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