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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 K990728
Device Name THERMAL CAUTERY DEVICE, FORCEPS
Applicant
Starion Instruments
22900 Congress Springs Rd.
Saratoga,  CA  95070
Applicant Contact GEORGE D HERMANN
Correspondent
Starion Instruments
22900 Congress Springs Rd.
Saratoga,  CA  95070
Correspondent Contact GEORGE D HERMANN
Regulation Number886.4115
Classification Product Code
HQP  
Subsequent Product Code
GEI  
Date Received03/05/1999
Decision Date 06/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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