SURGICRAFT COPELAND DISPOSABLE

Electrode, Circular (spiral), Scalp And Applicator

A.W. SHOWELL (SURGICRAFT) LTD.

The following data is part of a premarket notification filed by A.w. Showell (surgicraft) Ltd. with the FDA for Surgicraft Copeland Disposable.

Pre-market Notification Details

Device IDK844608
510k NumberK844608
Device Name:SURGICRAFT COPELAND DISPOSABLE
ClassificationElectrode, Circular (spiral), Scalp And Applicator
Applicant A.W. SHOWELL (SURGICRAFT) LTD. BRITTEN ST. REDDITCH Worcs. B97 6hf England,  GB
ContactShowell
CorrespondentShowell
A.W. SHOWELL (SURGICRAFT) LTD. BRITTEN ST. REDDITCH Worcs. B97 6hf England,  GB
Product CodeHGP  
CFR Regulation Number884.2675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-27
Decision Date1985-05-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055270977168 K844608 000
05055270977137 K844608 000

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