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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K924016
Device Name SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
Applicant
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Applicant Contact KEVIN W SMITH
Correspondent
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Correspondent Contact KEVIN W SMITH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/11/1992
Decision Date 12/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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