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 Table, Operating-Room, Ac-Powered
510(k) Number K930493
Device Name QUANTUM 3080 SURGICAL TABLE
Applicant
AMERICAN STERILIZER CO.
2424 WEST 23RD ST.
P.O. BOX 620
ERIE,  PA  16514
Applicant Contact MICHAEL ZMUDA
Correspondent
AMERICAN STERILIZER CO.
2424 WEST 23RD ST.
P.O. BOX 620
ERIE,  PA  16514
Correspondent Contact MICHAEL ZMUDA
Regulation Number878.4960
Classification Product Code
FQO  
Subsequent Product Code
FWW  
Date Received02/01/1993
Decision Date 06/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-