FDA Device Entity Profile: Sutter Medizintechnik GmbH

Known Identifiers & Locations

FEI Numbers 3004857377, 3012940012

Owner Operator Numbers 9005453

Locations Covered Alpharetta, GA, US; Emmendingen Baden-Wurttemberg, DE

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US	Repack or Relabel Medical Device	View Details
8044091	SUTTER MEDIZINTECHNIK GMBH	Emmendingen Baden-Wurttemberg, DE	Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K192128	Sutter Arrowtip Monopolar Electrodes	2019-10-04	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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