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 Container, I.V.
510(k) Number K875155
Device Name 60 ML RESERVOIR BAG, ITEM #200
Applicant
Prn Services, Inc.
1210 Morse
Royal Oak,  MI  48067
Applicant Contact FRED KAMIENNY
Correspondent
Prn Services, Inc.
1210 Morse
Royal Oak,  MI  48067
Correspondent Contact FRED KAMIENNY
Regulation Number880.5025
Classification Product Code
KPE  
Date Received12/15/1987
Decision Date 02/16/1988
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
-
-