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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 K854334
Device Name PAINBLOCKER WA5000
Applicant
Wallach Surgical Devices, Inc.
291 Pepe'S Farm Rd.
Milford,  CT  06460
Applicant Contact VINCENT FRAZZETTA
Correspondent
Wallach Surgical Devices, Inc.
291 Pepe'S Farm Rd.
Milford,  CT  06460
Correspondent Contact VINCENT FRAZZETTA
Regulation Number882.4250
Classification Product Code
GXH  
Date Received10/28/1985
Decision Date 04/30/1986
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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