Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pump, Infusion
510(k) Number K031432
Device Name KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
Applicant
Hk Surgical, Inc.
2620a Temple Heights Dr.
Oceanside,  CA  92675
Applicant Contact SALLY M BOWDON
Correspondent
Hk Surgical, Inc.
2620a Temple Heights Dr.
Oceanside,  CA  92675
Correspondent Contact SALLY M BOWDON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/06/2003
Decision Date 08/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-