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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K894186
Device Name SURGIFLEX LASER CONTACT TIPS
Applicant
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Applicant Contact TODD J POLK
Correspondent
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Correspondent Contact TODD J POLK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/16/1989
Decision Date 09/12/1989
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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