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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 K803311
FOIA Releasable 510(k) K803311
Device Name LL100 CRYOSURGICAL SYSTEM
Applicant
Wallach Surgical Devices, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wallach Surgical Devices, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4350
Classification Product Code
GEH  
Date Received01/02/1981
Decision Date 02/04/1981
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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