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 Lubricant, Patient
510(k) Number K864556
Device Name AQUALUBE(TM)
Applicant
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Applicant Contact MARTIN BUCHALTER
Correspondent
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Correspondent Contact MARTIN BUCHALTER
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received11/19/1986
Decision Date 12/01/1986
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
-
-