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 Catheters, Suction, Tracheobronchial
510(k) Number K843797
Device Name STERILE SALINE SOLUTION
Applicant
Paco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood,  NJ  08701
Correspondent
Paco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood,  NJ  08701
Regulation Number868.6810
Classification Product Code
BSY  
Date Received09/27/1984
Decision Date 01/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-