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 Bed, Pediatric Open Hospital
510(k) Number K883818
Device Name MODIFIED REFLUX REDUCER
Applicant
Physician Engineered Products, Inc.
Hco6 Box 17
Park Rapids,  MN  56470
Applicant Contact ROSE, MD
Correspondent
Physician Engineered Products, Inc.
Hco6 Box 17
Park Rapids,  MN  56470
Correspondent Contact ROSE, MD
Regulation Number880.5140
Classification Product Code
FMS  
Date Received09/08/1988
Decision Date 11/21/1988
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
-
-