Dolomite Ab

FDA Filings

This page includes the latest FDA filings for Dolomite Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9615290
• FEI Number: 3005026453
• Name: GERARDCCLARKE
• Owner & Operator: DOLOMITE AB
• Contact Address: VAXJOVAGEN 303 --; DIO SE-NOTA 34375 SE
• US Agent:
  • GERARDCCLARKE
  • CLARKE HEALTH CARE PRODUCTS, INC.
  • 724 6952122
  • 724 6952922
  • INFO@CLARKEHEALTHCARE.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7830 Steubenville Pike ; Noblestown, PA 15071 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
FSA GERARDCCLARKE [DOLOMITE AB]	DOLOMITE	2002-06-17
ITJ GERARDCCLARKE [DOLOMITE AB]	DOLOMITE	1997-07-24
ITJ GERARDCCLARKE [DOLOMITE AB]	DOLOMITE ROLLATOR	1997-07-24