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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K921393
Device Name IMAGICA MICRO-ENDOSCOPE
Applicant
Fiberoptic Medical Products, Inc.
4000 Bell Atlantic Tower
1717 Arch St.
Philadelphia,  PA  19103
Applicant Contact JOHN REISS
Correspondent
Fiberoptic Medical Products, Inc.
4000 Bell Atlantic Tower
1717 Arch St.
Philadelphia,  PA  19103
Correspondent Contact JOHN REISS
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received03/23/1992
Decision Date 08/20/1992
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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