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 General Surgery Tray
510(k) Number K884093
Device Name STERILE DISPOSABLE SURGICAL PACKS
Applicant
Bolden Surgical Products
4729 Kinnamon Rd.
Winston-Salem,  NC  27103
Applicant Contact ALEXANDER LUCIO
Correspondent
Bolden Surgical Products
4729 Kinnamon Rd.
Winston-Salem,  NC  27103
Correspondent Contact ALEXANDER LUCIO
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/28/1988
Decision Date 10/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-