DRAPE, TRANSURETHRAL RESECTION (TUR)

Drape, Pure Latex Sheet, With Self-retaining Finger Cot

V. MUELLER O.V. BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by V. Mueller O.v. Baxter Healthcare Corp. with the FDA for Drape, Transurethral Resection (tur).

Pre-market Notification Details

Device IDK760175
510k NumberK760175
Device Name:DRAPE, TRANSURETHRAL RESECTION (TUR)
ClassificationDrape, Pure Latex Sheet, With Self-retaining Finger Cot
Applicant V. MUELLER O.V. BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEYX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-07-06
Decision Date1976-08-30

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