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 Shield, Nipple
510(k) Number K930238
Device Name BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS
Applicant
Prolac, Inc.
3 Lake View Cir.
Skaneateles,  NY  13152
Applicant Contact GERALD R MORRISSEY
Correspondent
Prolac, Inc.
3 Lake View Cir.
Skaneateles,  NY  13152
Correspondent Contact GERALD R MORRISSEY
Regulation Number880.5630
Classification Product Code
HFS  
Date Received01/19/1993
Decision Date 08/16/1993
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
-
-