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 Lavage, Jet
510(k) Number K874022
Device Name PHARMASEAL WOUND IRRIGATION DEVICE
Applicant
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Applicant Contact ROBERT T MERRICK
Correspondent
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Correspondent Contact ROBERT T MERRICK
Regulation Number880.5475
Classification Product Code
FQH  
Date Received10/02/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-