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 Orthopedic Manual Surgical Instrument
510(k) Number K921402
Device Name SURGICAL INSTRUMENT, DISPOSABLE
Applicant
Macro Medical, Inc.
5179 St. Imier Dr., Suite 100
Minneapolis,  MN  55421
Applicant Contact SHERRY MCPHILLIPS
Correspondent
Macro Medical, Inc.
5179 St. Imier Dr., Suite 100
Minneapolis,  MN  55421
Correspondent Contact SHERRY MCPHILLIPS
Regulation Number888.4540
Classification Product Code
LXH  
Date Received03/24/1992
Decision Date 06/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-