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 Apparatus, Exhaust, Surgical
510(k) Number K912347
Device Name BIPURE 1000
Applicant
Laser Engineering, Inc.
113 Cedar St.
Milford,  MA  01757
Applicant Contact ROBERT I.RUDKO
Correspondent
Laser Engineering, Inc.
113 Cedar St.
Milford,  MA  01757
Correspondent Contact ROBERT I.RUDKO
Regulation Number878.5070
Classification Product Code
FYD  
Date Received05/28/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-