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, suction, single patient use, portable, nonpowered
510(k) Number K780848
Device Name PORTABLE CLOSED WOUND SUCTION EVACUATOR
Applicant
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4680
Classification Product Code
GCY  
Date Received05/23/1978
Decision Date 08/23/1978
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
-
-