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 Dressing, Wound, Occlusive
510(k) Number K871495
Device Name BANDAGES CATALOG NUMBER: 101 TO 220
Applicant
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Applicant Contact AMIR PORAT
Correspondent
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Correspondent Contact AMIR PORAT
Regulation Number878.4020
Classification Product Code
NAD  
Date Received04/16/1987
Decision Date 05/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-