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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K951937
Device Name BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)
Applicant
Bio Path
774 Mays Blvd. #10-236
Incline Village
Lake Tahoe,  NV  89451
Applicant Contact LYNN WYMAN
Correspondent
Bio Path
774 Mays Blvd. #10-236
Incline Village
Lake Tahoe,  NV  89451
Correspondent Contact LYNN WYMAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/25/1995
Decision Date 06/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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