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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K914247
Device Name ASPIRATING ENDO OCULAR PROBE
Applicant
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact ALAN T BECKMAN
Correspondent
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact ALAN T BECKMAN
Regulation Number874.4350
Classification Product Code
EQH  
Date Received09/23/1991
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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