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 Arthroscope
510(k) Number K910164
Device Name ORTHOCONCEPT ARTHROSCOPIC PUMP
Applicant
Orthoconcept, Inc.
605 E. 63rd. St.
Suite 7a
New York City,  NY  10021
Applicant Contact JACK DEFRANCO
Correspondent
Orthoconcept, Inc.
605 E. 63rd. St.
Suite 7a
New York City,  NY  10021
Correspondent Contact JACK DEFRANCO
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/15/1991
Decision Date 03/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-