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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 K941158
Device Name FLEXIBLE BIOPSY CUP FORCEPS
Applicant
SURGICAL TECHNOLOGIES, INC.
4715 N.W. 157TH ST., SUITE 212
MIAMI LAKES,  FL  33014
Applicant Contact LASZLO FAZEKAS
Correspondent
SURGICAL TECHNOLOGIES, INC.
4715 N.W. 157TH ST., SUITE 212
MIAMI LAKES,  FL  33014
Correspondent Contact LASZLO FAZEKAS
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received03/11/1994
Decision Date 04/28/1994
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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