WILTEK BALLOON STONE EXTRACTOR— 510(k) K894865

Substantially Equivalent

Wiltek Medical, Inc.

FDA 510(k) clearance K894865 for WILTEK BALLOON STONE EXTRACTOR, Substantially Equivalent on 1989-12-21. Applicant: Wiltek Medical, Inc..

Clearance details

Applicant
Wiltek Medical, Inc.
Product code
Code LQR
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Winston-Salem, NC, US
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