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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K992983
Device Name BAHO AUTOCLAVABLE CYSTOSCOPE
Applicant
INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
1112 WESTON RD., SUITE 227
FT. LAUDERDALE,  FL  33326
Applicant Contact GERALD GOIGITZER
Correspondent
INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
1112 WESTON RD., SUITE 227
FT. LAUDERDALE,  FL  33326
Correspondent Contact GERALD GOIGITZER
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received09/03/1999
Decision Date 10/07/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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