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 Laparoscope, General & Plastic Surgery
510(k) Number K003871
Device Name LAPAROSCOPIC HAND PORT
Applicant
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact ANIL BHALANI
Correspondent
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact ANIL BHALANI
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/15/2000
Decision Date 05/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-