VERSA-VU

Speculum, Vaginal, Nonmetal

COOPERSURGICAL, INC.

The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Versa-vu.

Pre-market Notification Details

Device IDK951898
510k NumberK951898
Device Name:VERSA-VU
ClassificationSpeculum, Vaginal, Nonmetal
Applicant COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton,  CT  06484
ContactJohn Chapman
CorrespondentJohn Chapman
COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton,  CT  06484
Product CodeHIB  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-24
Decision Date1995-12-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937000115 K951898 000
00888937000078 K951898 000

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