URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT

Catheter, Urological

BIOSEARCH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Urinary Intermittent Catheters W/o Hydromer Hydrophilic Lubricant.

Pre-market Notification Details

Device IDK951260
510k NumberK951260
Device Name:URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
ClassificationCatheter, Urological
Applicant BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville,  NJ  08876
ContactMartin Dyck
CorrespondentMartin Dyck
BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville,  NJ  08876
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-21
Decision Date1995-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10801741078054 K951260 000
10801741077934 K951260 000
10801741077941 K951260 000
10801741077958 K951260 000
10801741077965 K951260 000
10801741077972 K951260 000
10801741077989 K951260 000
10801741077996 K951260 000
10801741078009 K951260 000
10801741078016 K951260 000
10801741078023 K951260 000
10801741078030 K951260 000
10801741078047 K951260 000
10801741077927 K951260 000

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