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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K931793
Device Name SYMBIOSIS ENT SURGICAL INSTRUMENTS
Applicant
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Applicant Contact KEVIN W SMITH
Correspondent
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Correspondent Contact KEVIN W SMITH
Regulation Number874.4420
Classification Product Code
LRC  
Date Received04/12/1993
Decision Date 07/22/1993
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
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