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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K002752
Device Name BAYONET FORCEPS BIPOLAR IRRIGATING
Applicant
Q2 Medical
2400 Crittenden Dr.
Louisville,  KY  40217
Applicant Contact ERIC MILLS
Correspondent
Q2 Medical
2400 Crittenden Dr.
Louisville,  KY  40217
Correspondent Contact ERIC MILLS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/05/2000
Decision Date 11/20/2000
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
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