• 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 K973485
Device Name CLEARVIEW BLOWER/MISTER
Applicant
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Applicant Contact GRETCHEN HARTLAGE
Correspondent
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Correspondent Contact GRETCHEN HARTLAGE
Regulation Number880.5475
Classification Product Code
FQH  
Date Received09/15/1997
Decision Date 12/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-