REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA

Insufflator, Hysteroscopic

WASHINGTON REGULATORY SERVICES

The following data is part of a premarket notification filed by Washington Regulatory Services with the FDA for Register, A Disposable Hysterography Cupula.

Pre-market Notification Details

Device IDK894259
510k NumberK894259
Device Name:REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
ClassificationInsufflator, Hysteroscopic
Applicant WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes,  NJ  08551
ContactRandolph Cooke
CorrespondentRandolph Cooke
WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes,  NJ  08551
Product CodeHIG  
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-20
Decision Date1990-03-05

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