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 Cover, Shoe, Operating-Room
510(k) Number K955835
Device Name FLUID BARRIER BOOT KNEE & ANKLE-HIGH
Applicant
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Applicant Contact BRENDA J SPARKS
Correspondent
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Correspondent Contact BRENDA J SPARKS
Regulation Number878.4040
Classification Product Code
FXP  
Date Received12/26/1995
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-