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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Bronchoscope (Rigid)
510(k) Number K990561
Device Name OPTICAL FORCEPS
Applicant
PILLING WECK SURGICAL
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Applicant Contact ELIZABETH LAZARO
Correspondent
PILLING WECK SURGICAL
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Correspondent Contact ELIZABETH LAZARO
Regulation Number874.4680
Classification Product Code
JEK  
Subsequent Product Codes
EOX   EWY  
Date Received02/22/1999
Decision Date 05/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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