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 Drape, Surgical
510(k) Number K864111
Device Name STERILE FIELD #605 FENESTRATED STERILE FIELD #606
Applicant
GRAHAM MEDICAL PRODUCTS
P.O. BOX 510, 56 CANAL ST.
HOLYOKE,  MA  01041
Applicant Contact W. L BAGGETT
Correspondent
GRAHAM MEDICAL PRODUCTS
P.O. BOX 510, 56 CANAL ST.
HOLYOKE,  MA  01041
Correspondent Contact W. L BAGGETT
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/21/1986
Decision Date 10/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-