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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Battery-Powered
510(k) Number K933079
Device Name ELECTROCAUTERY SYSTEM MODEL 1980
Applicant
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact DAVID COSTELLO
Correspondent
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact DAVID COSTELLO
Regulation Number886.4115
Classification Product Code
HQP  
Date Received06/23/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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