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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name guide, surgical, instrument
510(k) Number K914715
Device Name PARALLELING GUIDES
Applicant
IMPLANT CORP. OF AMERICA
2299 9TH AVE. NORTH, SUITE 1-E
ST. PETERSBURG,  FL  33713
Applicant Contact O.HILT TATUM
Correspondent
IMPLANT CORP. OF AMERICA
2299 9TH AVE. NORTH, SUITE 1-E
ST. PETERSBURG,  FL  33713
Correspondent Contact O.HILT TATUM
Regulation Number878.4800
Classification Product Code
FZX  
Date Received10/18/1991
Decision Date 02/16/1994
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
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