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 drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K011381
Device Name HUMMER IV MICRODEBRIDER SYSTEM
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact ROBIN L ROWE
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact ROBIN L ROWE
Regulation Number874.4250
Classification Product Code
ERL  
Date Received05/07/2001
Decision Date 05/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-