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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Ac-Powered
510(k) Number K972749
Device Name PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
Applicant
C.M. Chance , Ltd.
1018 St. Rd., Suite 201
Southampton,  PA  18966
Applicant Contact DAVID PAO
Correspondent
C.M. Chance , Ltd.
1018 St. Rd., Suite 201
Southampton,  PA  18966
Correspondent Contact DAVID PAO
Regulation Number886.4100
Classification Product Code
HQR  
Date Received07/23/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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