510(k) Premarket Notification

• Device Classification Name: set, i.v. fluid transfer
• 510(k) Number: K001368
• Device Name: PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
• Applicant: CARMEL PHARMA AB.; BOX 5352; GOTHENBURG, SE 40228
• Applicant Contact: KJELL ANDREASSON
• Correspondent: CARMEL PHARMA AB.; BOX 5352; GOTHENBURG, SE 40228
• Correspondent Contact: KJELL ANDREASSON
• Regulation Number: 880.5440
• Classification Product Code: LHI
• Date Received: 05/01/2000
• Decision Date: 05/12/2000
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General Hospital
• Type: Special
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls