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 Needle, Acupuncture, Single Use
510(k) Number K964529
Device Name CW ACUPUNCTURE NEEDLES
Applicant
Lhasa Medical, Inc.
234 Libbey Pkwy.
Weymouth,  MA  02189
Applicant Contact KYUNG SOON RIIHIMAKI
Correspondent
Lhasa Medical, Inc.
234 Libbey Pkwy.
Weymouth,  MA  02189
Correspondent Contact KYUNG SOON RIIHIMAKI
Regulation Number880.5580
Classification Product Code
MQX  
Date Received11/12/1996
Decision Date 01/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-