PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME

Cystotome

ADVANCED SURGICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Prisma Disposable Straight Irrigating Cystotome.

Pre-market Notification Details

Device IDK874997
510k NumberK874997
Device Name:PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
ClassificationCystotome
Applicant ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield,  MO  63017
ContactTodd J Hessel
CorrespondentTodd J Hessel
ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield,  MO  63017
Product CodeHNY  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-02
Decision Date1988-04-13

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