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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K893871
Device Name GOOTT BALFOUR BLADE
Applicant
Adept-Med Intl., Inc.
3293 Saratoga Ln.
P.O. Box 1777
Cameron Park,  CA  95682
Applicant Contact KATHLEEN QUIGLEY
Correspondent
Adept-Med Intl., Inc.
3293 Saratoga Ln.
P.O. Box 1777
Cameron Park,  CA  95682
Correspondent Contact KATHLEEN QUIGLEY
Regulation Number878.4800
Classification Product Code
GAD  
Date Received05/26/1989
Decision Date 08/03/1989
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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